ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Reported: September 7, 2022 Initiated: July 26, 2022 #Z-1660-2022
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.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 2451 kits of 100 tests
- Distribution
- Nationwide
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27. Recalled by Abbott Laboratories. Units affected: 2451 kits of 100 tests.
Why was this product recalled? ▼
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1660-2022.
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