medical Class II Updated 2024-01-24

Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351

Recalled Product

Calibration Serum Level 3 CAL2351


Hazard / Issue

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
View official government recall

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