Z-1660-2022 Class II Ongoing
FDA device recall Z-1660-2022 was initiated by Abbott Laboratories on Jul 26, 2022 and is designated Class II. Reason for recall: One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. The recall status is ongoing. Affected quantity: 2451 kits of 100 tests.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 7, 2022
- Initiation Date
- Jul 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2451 kits of 100 tests
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.
Distribution Pattern
Nationwide
Code Information
UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1660-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026