Reported May 20, 2020 · Terminated
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294…
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 · 513 Technology Blvd · Rochester, NY · 14626-3601
Is this the product you have?
- VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI
- Number 10758750004294 - Product UsageThe VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction
- Lot codes and dates
CKMB Slides that expire after July 202018 and within current expiry
- Amount recalled
- N/A
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
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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