Reported Jul 5, 2023 · Ongoing
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the…
Randox Laboratories Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
- Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility
- of analytes Catalog NumberIA2633
- Lot codes and dates
- GTIN05055273203837
- Batch/Lot Number583135 Exp
- Date28th April 23
- Amount recalled
- 30 kits
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
Why it was recalled
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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