Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0666-2019 — Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

U.S. FDA — Device Enforcement · Ireland · 2018-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0666-2019
Date of alert
2018-11-21
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Abbott Ireland Diagnostics Division
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00380740160616
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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