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Terminated

Alinity i Progesterone Reagent Kit, List Number 08P3620

FDA Recall Z-0668-2019 · Posted None

Recalling FirmAbbott Ireland Diagnostics Division
Recall StatusTerminated
Product CodeJLS
Date Initiated2018-11-21
Date Terminated2021-04-01
Product Quantity157 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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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