Sentinel CH SpA recalls Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHI…

Recall date

June 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2552-2019

FDA classification

Class II

Brand / firm

Sentinel CH SpA

Sold / distributed

Nationwide Foreign: ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BANGLADESH BELARUS BELGIUM BOSNIA AND HERZEGOVI BRAZIL BRUNEI CANADA CHILE COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK FAROE ISLANDS FINLAND FRANCE GERMANY GREECE GREENLAND HONG KONG IRELAND ISRAEL ITALY JORDAN KUWAIT LEBANON LUXEMBO…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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