FDA Device recall Z-1097-2022
CK MB Calibrator, Catalogue Number CK2393
- FDA Device
- Class III
- terminated
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class III recall of CK MB Calibrator, Catalogue Number CK2393 by Randox Laboratories, citing randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1097-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-03-25 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | GA, PR, WV |
Product
CK MB Calibrator, Catalogue Number CK2393
Reason
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
Identifiers
| code_info | GTIN 05055273201451 Lot 4410CK |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1097-2022%22
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