Recall Z-1696-2023— Abbott Ireland Limited

Name: FDA recall Z-1696-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-24

Class III · Ongoing

Class III FDA medical device recall by Abbott Ireland Limited, initiated 2023-04-24. It names one FDA 510(k) clearance: K052407. Product: Alinity i Anti-TPO Reagent Kit, List Number 09P3521. Reason: Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU)..

Recalling firm: Abbott Ireland Limited
Classification: Class III
Status: Ongoing
Initiated: 2023-04-24
Firm location: Sligo, Ireland

510(k) clearances named in this recall

1 on FDA's record

K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSFisher Diagnostics·cleared 2006-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Reason for recall

Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

Data sourced from openFDA. This site is unofficial and independent of the FDA.