medical Class II Updated 2019-10-02

Sentinel CH SpA recalls MULTIGENT Lithium-intended for the quantitation of lithium i

Recalled Product

MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30

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: 71175Y600 (01)003807400177712(17)191031(10)71175Y600; 80362Y600 (01)003807400177712(17)200131(10)80362Y600; 80201Y600 (01)003807400177712(17)200131(10)80201Y600; 80533Y600 (01)003807400177712(17)200630(10)80533Y600; 80463Y600 (01)003807400177712(17)200630(10)80463Y600; 80424Y600 (01)003807400177712(17)200630(10)80424Y600; 80605Y600 (01)003807400177712(17)200930(10)80605Y600; 90208Y600 (01)003807400177712(17)210131(10)90208Y600

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