medical Class II Updated 2019-10-02

Sentinel CH SpA recalls Alinity c Lithium Reagent Kit- intended for the quantitation

Recalled Product

Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320


Hazard / Issue

Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number/UDI: 80553Y600/ (01)00380740136277 (17)190731(10)80553Y600; 80444Y600/ (01)00380740136277 (17)190731(10)80444Y600; 80625Y600/ (01)00380740136277 (17)191130(10)80625Y600; 90224Y600/ (01)0038074013627 (17)200229(10)90224Y600
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