Human alpha 1 antitrypsin Kit for use on SPAPLUS NK034.SRecalls & reported problems
The Binding Site Group Limited · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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.
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 18, 2026.
Recalls naming this device
- Aug 23, 2017Class IITerminated
The high control for the kit is recovering low and may be out of range for assigned values.
Z-0002-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Alpha-1-Antitrypsin, Antigen, Antiserum, Control devices
- Albumin BCP 5599261190Roche Diagnostics GmbH · ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL2 reports
- Tinaquant 1Antitrypsin ver2 5991978190Roche Diagnostics GmbH · ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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