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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Laryngoscope, endoscope - Product Code GCI
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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.
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
Transformer, endoscope - Product Code GCW
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Transformer, endoscope - Product Code GCW
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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, testosterones and dihydrotestosterone - Product Code CDZ
Causa
Asfotase alfa (strensiq) interferes with certain tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Acción
The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following:
*Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa.
" For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology.
" Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment.
" Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: biorecallresponse@tosoh.com or Regular mail: 3600 Gantz Rd., Grove City, OH 43123.
" Maintain this notification with your laboratory records and forward this information to others who may have received this product.
" If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764.
Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: bernadette.oconnell@tosoh.com. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
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.
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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.
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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.
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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.
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Box, battery, pocket - Product Code FCP
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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, testosterones and dihydrotestosterone - Product Code CDZ
Causa
Asfotase alfa (strensiq) interferes with certain tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Acción
The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following:
*Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa.
" For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology.
" Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment.
" Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: biorecallresponse@tosoh.com or Regular mail: 3600 Gantz Rd., Grove City, OH 43123.
" Maintain this notification with your laboratory records and forward this information to others who may have received this product.
" If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764.
Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: bernadette.oconnell@tosoh.com. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
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
Staple, implantable - Product Code GDW
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Dissector, surgical, general & plastic surgery - Product Code GDI
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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 affected s2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. the error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected s2 fluid pack is replaced.
Acción
Roche Diagnostics sent an Urgent Medical Device Correction dated July 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers are asked to do the following:
1. Keep in the inventory a backup S2 Fluid Packs from an unaffected lot, or at least four additional S2 Fluid Packs from the affected lots when product from unaffected lots is not available.
2. If the S2 Fluid Pack generates a Transponder error message, contact the Roche Support Network Customer Support Center at 1-800-526-2272 (provide the lot and serial number printed on the side of the affected S2 Fluid Pack).
3. After contacting Roche Support Network Customer Support Center, dispose of the affected S2 Fluid Pack per local guidelines.
Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272, if you have questions about the information contained in this 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
Staple, implantable - Product Code GDW
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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.
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Lavage, jet - Product Code FQH
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Insufflator, laparoscopic - Product Code HIF
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Transcatheter septal occluder - Product Code MLV
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Transcatheter septal occluder - Product Code MLV
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
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
Wire, guide, catheter - Product Code DQX
Causa
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Acción
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.