Sentinel CH SpA Recalls Alinity c Lithium Reagent Kits
Sentinel CH SpA is recalling Alinity c Lithium Reagent Kits due to a potential carryover issue that may result in falsely elevated lithium patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic reagent) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Sentinel CH SpA is recalling 1,217 units of the Alinity c Lithium Reagent Kit (List Number 08P5320). The product is intended for the quantitation of lithium in serum or plasma using the ARCHITECT c Systems and the Alinity c analyzer.
The recall was initiated to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56). This carryover may result in falsely elevated lithium patient results. The affected lots are 80553Y600, 80444Y600, 80625Y600, and 90224Y600.
The product was distributed nationwide and in numerous foreign countries, including Argentina, Australia, Austria, and the United Kingdom. Healthcare facilities and laboratories should stop using the affected kits and contact Sentinel CH SpA for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Sentinel CH SpA
- Hazard
- Affected units
- 1,217
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 (4)
- 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
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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