Immunoassay Premium Level 3-In vitro diagnostic use — Class III medical device recall Z-2021-2023
Ongoing recall by Randox Laboratories Ltd., reported 2023-07-05, distributed in CA, IL, PR, VA, WA, WI. Delay in reporting results due to Quality Controls running high outside of range. Target value and range for A
| Recall number | Z-2021-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2023-05-04 |
| Classified | 2023-06-28 |
| Reported by FDA | 2023-07-05 |
| Distributed | CA, IL, PR, VA, WA, WI |
| Quantity | 1 kits |
| UPC / GTIN / UDI-DI | 05055273203868 |
| Lot numbers | 2031EC, 28TH |
| Model numbers | IA2640 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2021-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.