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
Quality Control kit for culture media - Product Code JTR
Causa
Incorrect micro-organism-- .Quality control in-vitro diagnostic test was manufactured with cryptococcus neoformans (atcc 76484) instead of haemophilus parainfluenzae (atcc 7901).
Acción
On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification.
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
Quality Control kit for culture media - Product Code JTR
Causa
Incorrect micro-organism-- quality control in-vitro diagnostic test was manufactured with cryptococcus neoformans (atcc 76484) instead of haemophilus parainfluenzae (atcc 7901).
Acción
On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification.
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
Nucleic Acid Amplification Assay System, (Group b streptococcus, direct specimen test) - Product Code NJR
Causa
Labeling error: some cartridges may be mislabeled as "xpert ev" instead of "xpert gbs". (the information embedded in the barcode label on the cartridge is correct for xpert gbs and brings up the gbs assay definition file).
Acción
Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label. They are asked to discontinue using it immediately and return to Cepheid.
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
Quality Control for Culture Media Kit - Product Code JTR
Causa
Mislabeled: duopacks of proteus vulgaris contained listeria monocytogenes instead of the labeled proteus vulgaris.
Acción
Consignees were initially notified of this recall by a telephone survey. An Urgent Product Recall letter was sent on 10/17/07 explaining the risk to patients. The firm sent replacements of the recalled product on 10/17/07 or 10/18/07, with request for acknowledgement of Recall Notification, and certification of disposal of incorrect product.
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.
The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/ml) for the architect afp assay file for the architect afp non-u.S. product. the assay labeling indicates that the limit flag should be set no lower than 20 ng/ml.
Acción
Abbott affiliates were e-mailed copies of the Product Correction (Immediate Action Required) Recall Letter on 9/18/07 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated 18 September 2007 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed that current AFP file has been updated on a new ARCHITECT I Assay CD-ROM (LN 6E59, version 24). The Low-Linearity flag threshold for the Amino 1:50 dilution has changed from 15 ng/mL to 20 ng/mL for consistency with overall assay sensitivity. The accounts were advised to install the updated version of the current ARCHITECT AFP assay when they receive the version 24 ARCHITECT I Assay CD-ROM. The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 9/28/07 at 1-800-777-0051.
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
Anti-HBc IGM EIA kit, - Product Code LOM
Causa
Incorrect instruction: the package insert states to add 100l of conjugate; it should state to add 100ul.
Acción
On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.
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
ELISA Kit - Product Code MID
Causa
Mislabeling: errors (control values) identified in the qc fact sheet for a specific lot of aphl hrp igg and igm test kits.
Acción
Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.
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
ELISA Kit - Product Code MID
Causa
Mislabeling: errors (control values) identified in the qc fact sheet for a specific lot of aphl hrp igg and igm test kits.
Acción
Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.
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
ELISA Kit - Product Code MID
Causa
Mislabeing : errors (control values) identified in the qc fact sheet for a specific lot of aphl hrp igg and igm test kits.
Acción
Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.
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
in vitro diagnostic - Product Code DDC
Causa
Low end imprecision affecting both s0 calibrators and patient samples which can lead to inaccurate low level patient results when using the access thyroglobulin antibody assay.
Acción
A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days.
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
Hepatitis C Test (Home) - Product Code MZO
Causa
Wrong expiration date; the kits were labeled with expiration/use by dates; that exceed the expiration dates of the sterile safety lancet component of the kit.
Acción
Recall letters dated 10/6/06 were sent to the direct accounts via FedEx on the same date. The accounts were informed of incorrect Use By dates on the kits based on the lancet component of the kit, and that the lancet may not be sterile as of the printed Use By date on the kit. The letters listed the specific products and affected lot numbers shipped to the individual account, and requested them to examine their inventory for the affected product and return it via UPS to Home Access for replacement. No test results will be provided to any customer who uses the affected product after 10/31/06. Any questions were directed to 1-800-871-6046.
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
Myoglobin, Antigen, Antiserum, Control - Product Code DDR
Causa
Some of the kits were shipped at the incorrect shipping temperature. they were shipped ambient, but should have been shipped frozen.
Acción
Abbott telephoned the laboratory end users on 10/17/05, informing them that Abbott discovered that ARCHITECT STAT Myoglobin Calibrators, lot V96128, were shipped to their facilities using the incorrect shipping conditions between August 29th and September 20th 2005. The kits should have been shipped frozen, but were shipped ambient. The error has been corrected. All shipments made after September 21, 2005 have been shipped correctly. Any data generated to date using this kit of calibrators is acceptable, providing that a valid calibration was achieved and product labeling was followed. However, long term use of this kit may result in calibration failures or controls out of range. The accounts were requested to mark the kit(s) of this lot currently in inventory to distinguish them from the replacement kit(s) Abbott will be sending to them. As a precaution, Abbott requested the labs to discontinue use of these kits and destroy them the replacement kits are received.
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.
Data reduction program written for specific sutomated microtiter plate insturment (bio-tek elx800 reader) is faulty in that the positive result limit is to be greater than 15 u/ml, rather than greater than or equal to 15 u/ml.
Acción
Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.
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.
Varicella zoster elisa kit assay was producing invalid runs on the eti-max 3000 automated microtiter plate instrument and/or false negative results.
Acción
Kit was initially placed on hold. Later Kit was discontinued and an alternate which would run correctly on the ETI-Max 3000 automated platform was found and offered to 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.
The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.
Acción
BD Diagnostic Systems notified end users by letter dated October 2004. The firm''s sales representatives delivered the letters initially on 10/29/04. The letter advises end users to examine identified lots for defects using a diagram provided with the notification and discard any suspect product for replacement. A response form is included with the notification.
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.
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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.
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antisera, Fluorescent, All Globulins, Proteus Spp. - Product Code GSY
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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.
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antisera, Fluorescent, All Globulins, Proteus Spp. - Product Code GSY
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antiserum, Positive And Negative Febrile Antigen Control Serum - Product Code GSN
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. - Product Code GNC
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. - Product Code GNC
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. - Product Code GNC
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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.
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.