Lower risk Medical device recall · FDA · Published April 30, 2021

Sentinel CH ACE Control Set Recall: Stability Issues After Reconstitution

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2012-2021Medical device Sentinel CH ›

Lower-risk recall

Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.

Take action

Contact the company

Recalling firmSentinel CH SpAVia Robert Koch 2 · Milan, Italy

✎ GovInfoNow plain-language explainer

Sentinel CH SpA is recalling ACE Control Sets used for measuring Angiotensin Converting Enzyme (ACE) because they may not stay stable after being reconstituted from powder. This could lead to inaccurate test results if used improperly. Read more at govinfonow.com/recall/62632-sentinel-ch-ace-control-set-recall-stability-issues-after-reconstitution.

Source Summary by GovInfoNow · govinfonow.com/recall/62632-sentinel-ch-ace-control-set-recall-stability-issues-after-reconstitution · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2012-2021

Cite this page

“Sentinel CH ACE Control Set Recall: Stability Issues After Reconstitution.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62632-sentinel-ch-ace-control-set-recall-stability-issues-after-reconstitution. Based on FDA recall #Z-2012-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2012-2021%22&limit=1).

Sentinel CH SpA recalled ACE Control Set IVD kits due to stability claim failures, according to the FDA. The agency announced the recall on April 30, 2021.

How to tell if you have it

Brand: Sentinel CH
Product: ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE)
REF: 1667001
Lot Numbers/Exp. Date: 80516 31/07/2021; 80635 30/09/2021; 90092 31/12/2021; 90599 31/12/2021; 00118 31/12/2021; 00360 31/12/2021; 00610 31/12/2021; 00702 31/12/2021
Distribution: Worldwide, including US Nationwide, Australia, Austria, Bangladesh, Belgium, Canada, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Ireland, Israel, Italy, Jordan, New Zealand, Poland, Portugal, Serbia, South Africa, Spain, Sweden, The Netherlands, Turkey, U.A.E., UK

The hazard

The hazard is that the claim for stability after reconstitution from lyophilized to liquid form does not meet requirements. New IFU instructions for handling the product are provided to end users.

Context

GovInfoNow's records show Sentinel CH SpA has 3 other recalls on record since 2019-06-28. Other recent recalls of similar products include Iron Assay Kits for Potential False Results (2023-09-29), Alinity c CRP Vario Calibrator Kit with Incorrect Labeling (2021-07-29), and Alinity c Lithium Reagent Kit Recall (2019-06-28).

How to tell if you have this one

Check the product label for lot numbers: 80516 (exp. 31/07/2021), 80635 (exp. 30/09/2021), 90092 (exp. 31/12/2021), 90599 (exp. 31/12/2021), 00118 (exp. 31/12/2021), 00360 (exp. 31/12/2021), 00610 (exp. 31/12/2021), or 00702 (exp. 31/12/2021).

Brand
Sentinel CH
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for lot numbers listed in the recall notice to confirm if your ACE Control Set is affected.
Follow New Instructions
Use the updated instructions provided by Sentinel CH SpA to ensure accurate test results after reconstitution.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CANADA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, JORDAN, NEW ZEALAND, POLAND,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Apr 30, 2021Firm started the recall
Jul 6, 2021FDA classified it Class III
Jul 14, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62632-sentinel-ch-ace-control-set-recall-stability-issues-after-reconstitution">Sentinel CH ACE Control Set Recall: Stability Issues After Reconstitution (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2012-2021 (April 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2012-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.