Recall Z-1660-2022— Abbott Laboratories

Name: FDA recall Z-1660-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-26

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, initiated 2022-07-26. It names one FDA 510(k) clearance: K041192. Product: ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27. Reason: One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2022-07-26
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAYFisher Diagnostics·cleared 2004-08-12

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

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

Reason for recall

One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

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