Reported Oct 2, 2019 · Terminated
Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the…
Sentinel CH SpA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sentinel CH SpA · Via Robert Koch 2 · Milan · N/A
Is this the product you have?
- 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 Number08P5320
- Lot codes and dates
4 of 4 products · 4 lot codes
Recalled lot codes, grouped by product number 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
- Amount recalled
- 1217 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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