CK MB Calibrator, Catalogue Number CK2393
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is recalling CK MB Calibrator, Catalogue Number CK2393, lot number 4410CK. The company realigned the calibrator, which will cause a positive shift of approximately 6% in both Quality Controls and Patient Samples when used for calibration.
The recall affects 1,392 units distributed domestically to West Virginia and Puerto Rico, as well as internationally to numerous countries including Bangladesh, China, France, Germany, India, Italy, Mexico, Pakistan, Philippines, Poland, Russia, and Saudi Arabia. The affected product has GTIN 05055273201451. The source does not specify a remedy for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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, Quantity: 1,392 Lot/code info: GTIN 05055273201451 Lot 4410CK
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.