Reported Jan 11, 2023 · Ongoing
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and…
Randox Laboratories Ltd.
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: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry
- and immunoassay systems Catalog NumberPS2682 Control Level 1
- Lot codes and dates
- GTIN05055273204896 Lot Number/Exp
- Date
584LPC 28th Jun 23600LPC 28th Nov 23611LPC 28th Sep 24
- Amount recalled
- 146 units US
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
This product could cause temporary or reversible health problems — stop using it.
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