FDA Device recall Z-2551-2019
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c…
- FDA Device
- Class II
- terminated
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class II recall of MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c… 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-2551-2019 |
| 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
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
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: 71175Y600 (01)003807400177712(17)191031(10)71175Y600; 80362Y600 (01)00380740017…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 |
|---|
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-2551-2019%22
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