Reported Aug 14, 2019 · Terminated
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use,…
Randox Laboratories, Limited
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, Limited · Ardmore; 55 The Diamond Road · Crumlin, N/A · N/A
Is this the product you have?
- Human Assayed Multi-Sera Level 2, Model NO
- HN1530 Product UsageThis product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy
- Lot codes and dates
1306UN1308UN1309UN
- Amount recalled
- 149 (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 RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
This product could cause temporary or reversible health problems — stop using it.
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