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U.S. Department of Health and Human Services

Class 3 Device Recall CK MB Calibrator

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  Class 3 Device Recall CK MB Calibrator see related information
Date Initiated by Firm March 25, 2022
Create Date May 16, 2022
Recall Status1 Terminated 3 on December 26, 2023
Recall Number Z-1097-2022
Recall Event ID 90046
Product Classification Nad reduction/nadh oxidation, cpk or isoenzymes - Product Code CGS
Product CK MB Calibrator, Catalogue Number CK2393
Code Information GTIN 05055273201451 Lot 4410CK
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Firm notified customers via email on March 25, 2022. The distributors and customers were instructed to discard previous target sheet and perform calibration with the realigned target value provided with the letter. Also, to complete and return the response form 12187-QA to technical.service@randox.com.
Quantity in Commerce 1,392
Distribution Domestic distribution to WV and PR. International distribution to Bangladesh, Bosnia & Herzegovina, Botswana, China, Colombia, Costa Rica, Croatia, Egypt, Fiji, France, Georgia, Germany, Ghana, Greece, Grenada, Hong Kong, India, Iraq, Italy, Lithuania, Malaysia, Maldives, Malta, Mexico, Morocco, Mozambique, Nepal, Nigeria, Pakistan, Philippines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, South Korea, Switzerland, Thailand, Turkey, UK, Uruguay, Uzbekistan and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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