Trinity Biotech B1029-440Recalls & reported problems
Clark Laboratories, Inc. · Bartels ELISA Legionella Urinary Antigen · Class 2
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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391516744065), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (1 report).
2 FDA recall records 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
- Jul 22, 2025Open, Classified
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Z-2292-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 11, 2021Terminated
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Z-0382-2022 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination of Device Ingredient or Reagent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
LABORATORY USER INFORMED MANUFACTURER THAT THEIR NEW SHIPMENT OF LUA KITS B1029-440 LOT 056 WAS FOUND TO HAVE SOME SORT OF GEL/PRECIPITATE IN EVERY BOTTLE OF CONJUGATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12787010 ↗
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 · each report above links to its original FDA record
- 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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