Reported Mar 21, 2018 · Terminated
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Randox Laboratories
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 · 515 Industrial Blvd · Kearneysville, WV · 25430-2778
Is this the product you have?
- Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
- Lot codes and dates
- Catalog numbers
IA2633 (Lots: 398703402366)
- IA2638 (Lot 1666EC) IA2639 (Lots
1486EC1516EC1626EC) IA2640 (Lots 1517EC1668EC)
- Catalog numbers
- Amount recalled
- 117 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
- Nationwide
Why it was recalled
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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