FDA Device recall Z-0752-2024
Calibration Serum Level 3 CAL2351
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of Calibration Serum Level 3 CAL2351 by Randox Laboratories, citing CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patien….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0752-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-20 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Calibration Serum Level 3 CAL2351
Reason
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Identifiers
| code_info | GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0752-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.