Reported Aug 14, 2019 · Terminated
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Randox Laboratories, Limited
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, Limited · Ardmore; 55 The Diamond Road · Crumlin, N/A · N/A
Is this the product you have?
Assayed Bovine Multi-Sera Level 1Model No. AL1027
- Lot codes and dates
- 205SL
- Amount recalled
- 4 kits (US)
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
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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