Food, drugs, devices › Sentinel CH SPA
Device recall: MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination
Sentinel CH SPA (Milan, N/A) initiated this device recall on 22 May 2017; FDA lists 1 product record under event 77405, classified Class II.
FDA defines Class II as 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 4 Sep 2018. Initiation: voluntary: firm initiated. Sentinel CH SPA has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sentinel CH SPA, Milan, N/A, Italy.
Reason for recall
"Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration."
Distribution
"Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2867-2017 | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in… | 2356 kits Worldwide; US 206 kits | Class II | Terminated | 9 Aug 2017 |
Context
Other enforcement events for Sentinel CH SPA
| 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 |
| 28 Jun 2019 | MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems | Device | Class II | 2 |
| 22 Sep 2015 | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended | Device | Class II | 1 |
All 6 events for Sentinel CH SPA
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Sep 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.