Reported Aug 16, 2023 · Ongoing
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ORTHO-CLINICAL DIAGNOSTICS · Felindre Meadows · Bridgend, N/A · N/A
Is this the product you have?
- VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- Lot codes and dates
- Product Code6802301
- UDI-DI
10758750002504Lot No.: 4800
- Expiration Date10-Jun-2023
- Amount recalled
- 4,013 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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