FDA Device recall Z-2021-2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of ana…
- FDA Device
- Class III
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class III recall of Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of ana… by Randox Laboratories, citing 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 Immunoassa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2021-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-05-04 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | CA, IL, PR, VA, WA, WI |
Product
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
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
Identifiers
| code_info | GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2021-2023%22
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