Z-1097-2022 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- March 25, 2022
- Termination Date
- December 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,392
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.
Distribution Pattern
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.
Code Information
GTIN 05055273201451 Lot 4410CK