Recall Z-1097-2022— Randox Laboratories Ltd.
Class III · Terminated
Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2022-03-25, terminated 2023-12-26. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2022-03-25
- Terminated
- 2023-12-26
- Firm location
- Crumlin (North), N/A, Ireland
Product description
CK MB Calibrator, Catalogue Number CK2393
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.