ARCHITECT STAT Troponin-I Reagent Kit recall
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Why was ARCHITECT STAT Troponin-I Reagent Kit recalled?
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
- Product
- ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
- Recalling firm
- Abbott Laboratories
- Quantity
- 2451 kits of 100 tests
- Distribution
- Nationwide
- Recall date
- September 7, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)