Sentinel CH SpA: 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

Is my product affected?

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

• UPC 00380740136277
• UPC 0038074013627

Check against the official notice below — it lists the full affected range.

What happened

Sentinel CH SpA is recalling 1,217 Alinity c Lithium Reagent Kits used to measure lithium levels in blood samples on ARCHITECT c Systems and Alinity c analyzers. The kits may produce falsely elevated lithium patient results due to potential carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent when used on the same analyzer without proper washing between tests.

The recall affects kits distributed nationwide and internationally across numerous countries, including Canada, Australia, and throughout Europe. The affected lot numbers are 80553Y600, 80444Y600, 80625Y600, and 90224Y600. The source does not specify what action affected consumers or healthcare facilities should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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

Details from the source

Reason for recall: 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 Distribution: 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 PARA Quantity: 1217 kits 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 5023002019-06-27
• Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 5023152019-06-27
• Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 5023502019-06-27
• Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 5023552019-06-27
• Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 5038252019-06-27

All FDA (Device enforcement) recalls