FDA Device recall Z-2552-2019
Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and t…
- FDA Device
- Class II
- terminated
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class II recall of Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and t… by Sentinel Ch Spa, citing 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 ARC….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2552-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-28 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Sentinel Ch Spa |
| Distribution | US |
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
Reason
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
Identifiers
| code_info | Lot Number/UDI: 80553Y600/ (01)00380740136277 (17)190731(10)80553Y600; 80444Y600/ (01)00380740136277 (17)190731(10)…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2552-2019%22
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