Alinity i TSH Reagent Kit, List Number 07P4830
FDA Recall Z-0664-2019 · Posted None
Recalling FirmAbbott Ireland Diagnostics Division
Recall StatusTerminated
Product CodeJLW
Date Initiated2018-11-21
Date Terminated2021-04-01
Product Quantity678 units
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.
Firm Action
The firm initiated the recall by letter on 11/21/2018. The notice explained the problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units. The units will be replaced.
Root Cause
Nonconforming Material/Component
Distribution Pattern
AR, FL, GA, MD, OK, VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.