CK MB Calibrator, Catalogue Number CK2393
Reported: May 25, 2022 Initiated: March 25, 2022 #Z-1097-2022
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 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.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
CK MB Calibrator, Catalogue Number CK2393. Recalled by Randox Laboratories Ltd.. Units affected: 1,392.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2022. Severity: Low. Recall number: Z-1097-2022.
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