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.
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.
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.
The product may not remain stable after being reconstituted from lyophilized (powder) form into liquid. This instability could cause inaccurate test results if the kit is used without following the updated instructions provided by the manufacturer.
Users of ACE Control Sets for medical testing who purchased the product between 2021 with specific lot numbers listed in the recall notice. Laboratory staff and healthcare professionals using these kits are most at risk of inaccurate test results.
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).
Look for lot numbers listed in the recall notice to confirm if your ACE Control Set is affected.
Use the updated instructions provided by Sentinel CH SpA to ensure accurate test results after reconstitution.
The ACE Control Set may not stay stable after being reconstituted from powder, which could lead to inaccurate test results if not handled properly.
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), and 00702 (exp. 31/12/2021).
No, but you should follow the new instructions provided by Sentinel CH SpA to ensure accurate test results after reconstitution.
We’ve drafted a message you can send Sentinel CH to request your refund or repair — edit it as you like.
Subject: Recall Z-2012-2021 — Sentinel CH Sentinel CH Hello, I own a Sentinel CH that is covered by recall Z-2012-2021 from Sentinel CH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
