U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bilirubin (total and unbound) in the neonate test system - Product Code MQM
Causa
Neonatal bilirubin (nbili) parameter may have increased variability when the nbili concentration is greater than 12 mg/dl and the thb concentration exceeds the upper reportable range of greater than 25 g/dl.
Acción
An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers.
In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field
Safety Notice via hard copy, e-mail, and/or fax as determined by each countries
local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Bilirubin (total and unbound) in the neonate test system - Product Code MQM
Causa
Neonatal bilirubin (nbili) parameter may have increased variability when the nbili concentration is greater than 12 mg/dl and the thb concentration exceeds the upper reportable range of greater than 25 g/dl.
Acción
An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers.
In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field
Safety Notice via hard copy, e-mail, and/or fax as determined by each countries
local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i, lot 3jd018, for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays which was the result of calibrator value miscalculation.
Acción
Siemens issued an Urgent Medical Device Correction, on/about January 19, 2015, notifying customers about the product, problem, and action to be taken. Customers were instructed to update the calibrator values for Drug Calibrator 1, Lot 3JD018. All customerswere requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within (30) days. Field service personnel have been sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions were instructed to contact their local Siemens technical support representative. For questions regarding this recall call 914-631-8000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
Error in wizard2 barcode id label #023 content
may produce erroneous results.
Acción
Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the
barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks.
A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
Error in wizard2 barcode id label #023 content
may produce erroneous results.
Acción
Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the
barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks.
A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
Error in wizard2 barcode id label #023 content
may produce erroneous results.
Acción
Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the
barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks.
A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Counter (beta, gamma) for clinical use - Product Code JJJ
Causa
Error in wizard2 barcode id label #023 content
may produce erroneous results.
Acción
Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the
barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks.
A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Causa
The spare component anti-hbs cutoff calibrator, catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
Acción
Bio-Rad Laboratories Inc, sent an Urgent Product Correction letter dated May 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The recalled calibrator is a spare component which is sold separately from the MONOLISA Anti-HBs EIA Kit and the kit is not affected by this recall.
Customers were informed that testing was performed and the Anti-HBs 10 mLU/mL Calibrator was acceptable to use through the expiration date of the kit dated 2015-11-30.
Customers with questions can call the firm at 1-800-224-6723, option #2, then #3.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The architect c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Acción
Abbott notified thier affected consignees via phone or visit on 5/29/15. A follow up Product Recall notification letter dated June 4, 2015 was sent to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use of the product, Abbott representative will be make all necessary arrangements for replacing your impacted instruments(s), follow your laboratory protocol regarding the need to review previously reported patient results and retain this notification for laboratory records. For questions contact Customer Service at 1-877-4ABBOTT.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Low po2 results. qc failures of the po2 parameter, affecting primarily levels 1 and 2, caused by a calibration issue with the po2 parameter. this issue may not be detected since qc results can be below mean values, but still within 2 standard deviations (sd) limits. potential for erroneously low po2 results in patient samples, especially in blood samples with po2 values below 50 mmhg.
Acción
Roche sent an Urgent Medical Device Correction letter dated July 14, 2015 and the Fax Back form via UPS ground to the customers list. The letter identified the affected product, problem and actions to be taken. Consignees are instructed to discontinue use of affected Fluid Packs and discard them per local guidlines; and complete and return the enclosed faxback form and fax it to 1-888-943-5171 to receive replacement product for Fluid Packs from the affected lot. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Sensor, glucose, invasive - Product Code MDS
Causa
Medtronic minimed is recalling the guardian real-time continuous glucose monitoring system because it has a language translation error that impacts the finnish language. specifically, the monitor has a finnish translation error in predictive alerts setting: the on-screen finnish translation for low/high is reversed as high/low.
Acción
A Urgent Medical Device recall letter was sent to customers on 7/22/15 to inform them that the Guardian Real-Time Continuous Glucose Monitoring System System has a language translation error that impacts the Finnish language. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact Nordic Support Line 0-800-164-064.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Acid, lactic, enzymatic method - Product Code KHP
Causa
When both ports (serial and ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.
Acción
Siemens Healthcare issued Urgent Field Safety Notice sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on July 28, 2015, both in the United States and outside of the United States, for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 dual port LIS transmission feature.
Users are informed to: If the system is currently set up with dual LIS transmission enabled, one of the ports (either Serial or Ethernet) needs to be disabled. Instruction provided with the notification. Customer to complete Field Effectiveness Check Form to confirm receipt of the notice.
The resolution of this issue will be implemented in the next software release for the RAPIDPoint 500 system.
If you have any questions, contact Siemens Customer Care Center or your local Siemens technical support representative. Please fax this completed Customer Care form to (312) 275-7795.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Acid, folic, radioimmunoassay - Product Code CGN
Causa
Low red blood cell control recoveries and low results for red blood cell patient samples when using the advia centaur systems folate assay.
Acción
An Urgent Medical Device Recall (UMDR) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 27, 2015 to be delivered to customers on July 28, 2015. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 27, 2015. These notices inform the customer to discontinue use of ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent kit lots 54942, 56230 and 70673
and dispose of the remaining inventory per local regulations. The ADVIA Centaur Systems Folate red blood cell sample and control negative bias is minimal in the lower range of the assay and is more pronounced with increasing folate concentrations. The negative bias could lead to a misclassification of a patient as folate deficient. Siemens does not recommend a look back of previously tested patients. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall and completed the required actions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Radioimmunoassay, progesterone - Product Code JLS
Causa
Advia centaur systems progesterone kit lots ending in 268 have a high bias on results greater than 30 ng/ml
(95.4 nmol/l).
Acción
Siemens issued an Urgent Medical Device Correction (UMDC) was sent to affected Siemens Healthcare Diagnostics customers in the United States on January 27, 2015 to be delivered to customers on January 28, 2015. An Urgent Field Safety Notice (U FSN) was sent out for distribution to all customers outside the United States on January 27, 2015. These notices inform the customer of the potential to observe a high bias on patient sample with results greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. To mitigate the bias, Siemens instructs customers to dilute samples with values greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. In addition, Siemens informs customers to continue to follow Urgent Medical Device Correction 10819675, Rev. A and Urgent Field Safety notice 10819674, Rev A (Information Regarding the ADVIA Centaur Systems Calibrator E), dated September 2014.
Fax-back forms to be returned to confirm that the customers received the
Urgent Medical Device Correction.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Radioimmunoassay, progesterone - Product Code JLS
Causa
Advia centaur systems progesterone kit lots ending in 268 have a high bias on results greater than 30 ng/ml
(95.4 nmol/l).
Acción
Siemens issued an Urgent Medical Device Correction (UMDC) was sent to affected Siemens Healthcare Diagnostics customers in the United States on January 27, 2015 to be delivered to customers on January 28, 2015. An Urgent Field Safety Notice (U FSN) was sent out for distribution to all customers outside the United States on January 27, 2015. These notices inform the customer of the potential to observe a high bias on patient sample with results greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. To mitigate the bias, Siemens instructs customers to dilute samples with values greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. In addition, Siemens informs customers to continue to follow Urgent Medical Device Correction 10819675, Rev. A and Urgent Field Safety notice 10819674, Rev A (Information Regarding the ADVIA Centaur Systems Calibrator E), dated September 2014.
Fax-back forms to be returned to confirm that the customers received the
Urgent Medical Device Correction.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Radioimmunoassay, progesterone - Product Code JLS
Causa
Advia centaur systems progesterone kit lots ending in 268 have a high bias on results greater than 30 ng/ml
(95.4 nmol/l).
Acción
Siemens issued an Urgent Medical Device Correction (UMDC) was sent to affected Siemens Healthcare Diagnostics customers in the United States on January 27, 2015 to be delivered to customers on January 28, 2015. An Urgent Field Safety Notice (U FSN) was sent out for distribution to all customers outside the United States on January 27, 2015. These notices inform the customer of the potential to observe a high bias on patient sample with results greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. To mitigate the bias, Siemens instructs customers to dilute samples with values greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. In addition, Siemens informs customers to continue to follow Urgent Medical Device Correction 10819675, Rev. A and Urgent Field Safety notice 10819674, Rev A (Information Regarding the ADVIA Centaur Systems Calibrator E), dated September 2014.
Fax-back forms to be returned to confirm that the customers received the
Urgent Medical Device Correction.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Electrode, ion specific, sodium - Product Code JGS
Causa
Siemens healthcare diagnostics has confirmed an issue with advia chemistry xpt software version 1.0.2. the system may cause samples to remain in an inprocess state. test results
on a sample that is held inprocess will not transmit to the lis. manual intervention is necessary to complete the processing of the samples that are held inprocess.
Acción
Siemens Healthcare Diagnostics sent Urgent Medical Device Correction Letters (dated 2/11/2015) via FedEx to the domestic consignees informing users of the software issue with ADVIA Chemistry XPT Software Version 1.0.2. The letters included work instructions to handle the bug. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. For questions about in process samples, the event message 02 981 8728, or need assistance with mitigation solutions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. Urgent Field Safety Notice Letters were sent to the foreign consignees (distribution is determined at the country level). Field service personnel were notified of the Urgent Medical Device Correction Letter.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Electrode, ion specific, potassium - Product Code CEM
Causa
A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. the dilution check correction would be detected by qc; however, if not detected by qc, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.
Acción
An Urgent Medical Device Recall letter, dated February 2015, was provided to all Dimension¿ system customers who received the affected lot to notify them that Siemens confirmed customer complaints of failing dilution checks when using QuikLYTE Dilution Check lot 4MD707. The letter also instructed them to immediately discontinue use and discard all inventory of Dimension QuikLYTE¿ Dilution Check lot 4MD707. Siemens offered a no charge replacement with a non-impacted lot.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
Software anomaly; it is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. if this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.E., results could be believable or outside of the reportable range for the intended assay).
Acción
On 3/10/2015, URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2015-047, dated 3/10/2015) were sent to users notifying them of the issue and advising them of the required actions. Customers are to complete and return the Confirmation of Receipt no later than March 23, 2015. The firm is currently working on a resolution and will issue a follow up notification upon the software's availability. For questions, please contact Customer Technical Services at 1-800-421-3311.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Urinary homocystine (nonquantitative) test system - Product Code LPS
Causa
Deterioration in performance of the liquid stable (ls) 2-part homocysteine reagent resulting in under recovery.
Acción
Axis Shield sent an Urgent Field Safety Notice letter dated March 20, 2015 to their customers via email and written notice sent with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Recommended Action to Customer is as follows: Confirm receipt of FSN to Axis-Shield. Do not use the affected Reagent lots referenced in the safety notice. In the event of holding one of the affected lots, immediately contact Axis-Shield Product Support Department to arrange for replacement material and return any defective product to Axis-Shield. Complete reconciliation form. Complete acknowledgement of the safety notice within 10 working days. Ensure safety notice has been distributed and reviewed by all appropriate personnel within your organization. If further distribution of affected lots to another organization has been made, inform them of this Product Recall and provide a copy of this safety notice to them. Retain a copy of the safety notice for their records.
For any issues or concerns contact Axis-Shield via e-mail; MDL-AXD-Product-
Support@alere.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both immulite 2000 and immulite 2000xpi water bottles and liquid waste bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Acción
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both immulite 2000 and immulite 2000xpi water bottles and liquid waste bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Acción
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both immulite 2000 and immulite 2000xpi water bottles and liquid waste bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Acción
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both immulite 2000 and immulite 2000xpi water bottles and liquid waste bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Acción
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both immulite 2000 and immulite 2000xpi water bottles and liquid waste bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Acción
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.