Device recall: MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c…
Class II FDA enforcement event 83516. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
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
Sentinel CH SpA started this device recall on 28 Jun 2019. The firm address in the FDA record is in Milan. FDA put the recall in Class II. FDA event 83516 has 2 product records. The first FDA enforcement report date is 2 Oct 2019. The record gives the status Terminated, with the termination date 24 Jul 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Sentinel CH SpA, Milan, Italy.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 analyzer List Number: 8L25-30 | 15919 kits | Class II | Terminated | 2 Oct 2019 |
| 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 the Alinity c analyzer List Number: 08P5320 | 1217 kits | Class II | Terminated | 2 Oct 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Sep 2023 | IRON assay, Reference Numbers 6K95-41 and 6K95-30 | Device | Class II | 2 |
| 29 Jul 2021 | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the | Device | Class III | 1 |
| 30 Apr 2021 | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001 | Device | Class III | 1 |
| 22 May 2017 | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination | Device | Class II | 1 |
| 22 Sep 2015 | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2551-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 83516. https://recallregister.com/fda/ii/83516/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 83516?
- The event has 2 product records. The first record gives this quantity:
15919 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.