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ACE Control Set 1667001Recalls & reported problems

Sentinel Ch. SPA · ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Apr 30, 2021Open, Classified

    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.

    Z-2012-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Other Single (Specified) Analyte Controls (Assayed And Unassayed) devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page