FDA-Device2019-10-02Class II
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
Sentinel CH SpA
Hazard
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
Sold states
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 LUXEMBOURG MALAYSIA MALDIVES MEXICO MOROCCO NETHERLANDS NEW ZEALAND NIGERIA NORWAY OMAN PAKISTAN PANAMA PARAGUAY PHILIPPINES POLAND PORTUGAL PUERTO RICO ROMANIA RWANDA SAUDI ARABIA SLOVAKIA SOUTH AFRICA SPAIN ST. VINCENT SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UAE UNITED KINGDOM URUGUAY
Affected count
1217 kits
Manufactured in
Via Robert Koch 2, Milan, Italy
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2552-2019Don't want to check this manually?
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