Randox Laboratories Ltd. Recall 92344
Description: Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Randox Laboratories Ltd. Recall 92344 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2021-2023 |
| Event ID | 92344 |
| Event Description | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640 |
| Product Type | Devices |
| Distribution | CA, IL, VA, WA, WI including PR |
| Quantity | 1 kit |
| Recall Reason | 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 |
| Device Classification | 20230705 |
| Device Code Info | GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23 |
| Center Classification Date | 20230628 |
| Recall Initiation Date | 20230504 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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