Sentinel CH SpA Recalls MULTIGENT Lithium Reagent Kits
Sentinel CH SpA is recalling 15,919 MULTIGENT Lithium reagent kits due to a potential carryover issue that may cause falsely elevated patient results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential inaccurate test results (falsely elevated lithium levels) rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Sentinel CH SpA is recalling 15,919 kits of MULTIGENT Lithium reagent, intended for the quantitation of lithium in serum or plasma using the ARCHITECT c Systems and the Alinity c analyzer. The affected product is identified by catalogue number 8L25-30 and 08P5320.
The recall was initiated to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent, which may result in falsely elevated lithium patient results. The company added an additional SmartWash parameter to the Lithium and Alinity c Lithium Reagent Kit to address this issue.
The affected lots were distributed nationwide and to numerous foreign countries. Users of these reagent kits should stop using the affected lots and contact Sentinel CH SpA for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Sentinel CH SpA
- Hazard
- Affected units
- 15,919
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sentinel CH SpA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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