Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Hazard
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
What You Should Do
Remedy
Urgent Medical Device Correction letters dated 2/7/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Randox Technical Services.
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Products
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638
Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and repr
- Brand
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- UPC
- Lot codes: 440941 1720EC
Units Affected
58