FDAFDA · Food and drugs·Recall number Z-2551-2019
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
Published October 2, 2019 · Recall initiated: June 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Sentinel CH SpA
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.