FDA-Device2022-05-25Class III
CK MB Calibrator, Catalogue Number CK2393
Randox Laboratories Ltd.
Hazard
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.
Sold states
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.
Affected count
1,392
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
CK MB Calibrator, Catalogue Number CK2393
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1097-2022Don't want to check this manually?
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