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Randox Laboratories Ltd. Recall 90046

Description: CK MB Calibrator, Catalogue Number CK2393

Randox Laboratories Ltd. Recall 90046 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1097-2022
Event ID90046
Event DescriptionCK MB Calibrator, Catalogue Number CK2393
Product TypeDevices
DistributionDomestic 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.
Recall ReasonRandox 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.
Device Classification20220525
Device Code InfoGTIN 05055273201451 Lot 4410CK
Center Classification Date20220516
Recall Initiation Date20220325
Recalling FirmRandox Laboratories Ltd.
Initial Notification E-Mail
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