Randox Laboratories Ltd. Recall 90046
Description: CK MB Calibrator, Catalogue Number CK2393
Randox Laboratories Ltd. Recall 90046 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1097-2022 |
| Event ID | 90046 |
| Event Description | CK MB Calibrator, Catalogue Number CK2393 |
| Product Type | Devices |
| 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. |
| Quantity | 1,392 |
| Recall 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. |
| Device Classification | 20220525 |
| Device Code Info | GTIN 05055273201451 Lot 4410CK |
| Center Classification Date | 20220516 |
| Recall Initiation Date | 20220325 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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