VITROS Immunodiagnostic Products Troponin I ES recall
VITROS Immunodiagnostic Products Troponin I ES Calibrators
Why was VITROS Immunodiagnostic Products Troponin I ES recalled?
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
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?
Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.
- Product
- VITROS Immunodiagnostic Products Troponin I ES Calibrators
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Quantity
- 4,013 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- August 16, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)