Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Reported: July 5, 2023 Initiated: May 4, 2023 #Z-2022-2023
Product Description
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Reason for Recall
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 30 kits
- Distribution
- CA, IL, VA, WA, WI including PR
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633. Recalled by Randox Laboratories Ltd.. Units affected: 30 kits.
Why was this product recalled? ▼
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Low. Recall number: Z-2022-2023.
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