IgA IA3832Recalls & reported problems
Randox Laboratories Limited · The product is intended for the quantitative in vitro determination of IgA in serum or plasma. · Class 2
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- Nov 1, 2022Terminated
Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
Z-0362-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Iga, Antigen, Antiserum, Control devices
- Tina-quant IgA Gen.2 08057885190Roche Diagnostics GmbH · IGA, ANTIGEN, ANTISERUM, CONTROL4 reports
- Tinaquant IgA Gen2 3507343190Roche Diagnostics GmbH · IGA, ANTIGEN, ANTISERUM, CONTROL2 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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