Sentinel CH SpA recalls
Every recall we track for Sentinel CH SpA — 6 in all, from 2019–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
6 recalls since 2017.
All FDA recall records for Sentinel CH SpA since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 2 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Sentinel CH SpA product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Sentinel CH SpA recalls
4 shown- Lower riskMedical device
Sentinel CH SpA recalls IRON assay, Reference Numbers 6K95-41 and 6K95-30
Sentinel CH SpA recalls two iron assay kits (reference numbers 6K95-41 and 6K95-30) due to potential false elevated results and delayed patient reports. Affected kits may cause inaccurate blood test results.
Sentinel CHSep 29, 2023 - Lower riskMedical device
Sentinel CH SpA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of
Sentinel CH recalls Alinity c CRP Vario Calibrator Kit (ref 07P5605) due to incorrect vial labeling, which may prevent successful calibration of cardiac tests on Alinity c analyzers.
Sentinel CHJul 29, 2021 - Lower riskMedical device
Sentinel CH SpA recalls ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Sentinel CH SpA recalls ACE Control Set (IVD) due to stability concerns after reconstitution. Affected lots from 2021 with specific expiration dates. Users should follow new instructions to ensure accurate test results.
Sentinel CHApr 30, 2021 - Lower riskMedical device
Sentinel CH SpA recalls MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c
Sentinel CH recalls Multigent Lithium Reagent Kits (8L25-30, 08P5320) that may cause falsely elevated lithium test results due to carryover from LDH reagent. Consumers should check product labels for lot numbers.
Sentinel CHJun 28, 2019
Sentinel CH SpA recall questions
How many recalls has Sentinel CH SpA had?
6 recalls from Sentinel CH SpA are on record with U.S. safety agencies, from 2019–2023.
What is the most recent Sentinel CH SpA recall?
Sentinel CH SpA recalls IRON assay, Reference Numbers 6K95-41 and 6K95-30, dated Sep 29, 2023. Every Sentinel CH SpA recall is listed on this page, newest first.
What should I do if I have a recalled Sentinel CH SpA product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Sentinel CH SpA recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.