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
Reported: April 17, 2019 Initiated: February 7, 2019 #Z-1105-2019
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 58
- Distribution
- The products were distributed to the following US states: WV and Puerto Rico.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Randox Laboratories Ltd.. Units affected: 58.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Low. Recall number: Z-1105-2019.
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