Recall Z-2208-2019

Reason for recall

Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

FDA-determined cause: Device Design

Action taken

The firm, Abbott, initiated the recall by a "Product Recall Urgent - Immediate Action Required" letter dated 11/21/2018 to its consignees. The letter explained the product, problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units, use an alternate lot of the product if available; manually inspect each reagent cartridge in inventory before use; complete and return the Customer Reply Form via FAX #: 18007770051 or email: QAGCO@abbott.com. Even if you no longer have the instrument(s), please return the completed Customer Reply Form so that we can appropriately update our customer database; If you have forwarded the product to other laboratories, please inform them of this Product Recall and provide to them a copy of this letter; and retain this letter for your laboratory records. The units will be replaced. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.