Class II — Sentinel CH SpA
| Recalling firm | SENTINEL CH. SpA |
|---|---|
| Registered facility | SENTINEL CH. SPA (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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 |
| Quantity | 15919 kits |
| Distribution | Nationwide Foreign: ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BANGLADESH BELARUS BELGIUM BOSNIA AND HERZEGOVI BRAZIL BRUNEI CANADA CHILE COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK FAROE ISLANDS FINLAND FRANCE GERMANY GREECE GREENLAND HONG KONG IRELAND ISRAEL ITALY JORDAN KUWAIT LEBANON LUXEMBOURG MALAYSIA MALDIVES MEXICO MOROCCO NETHERLANDS NEW ZEALAND N… |
| Initiated | 2019-06-28 |
| Classified | 2019-09-20 |
| Terminated | 2020-07-24 |
| Recall number | Z-2551-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sentinel CH SpA (Z-2551-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83516/
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