MULTIGENT Lithium-intended for the quantitation of lithium in serum… — Class II medical device recall Z-2551-2019
Terminated recall by Sentinel CH SpA, reported 2019-10-02, distributed nationwide. Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L
| Recall number | Z-2551-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentinel CH SpA, Milan, Italy |
| Recall initiated | 2019-06-28 |
| Classified | 2019-09-20 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2020-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CO, CR, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IT, JO, KW, LB, LU, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PH, PK, PL, PT, PY, RO, SA, SE, SK, TH, TR, TW, UY, ZA |
| Quantity | 15,919 kits |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2551-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.