BD Multi-Check 349704Recalls & reported problems
Becton, Dickinson And Company · BD Multi-Check™ CD4 Low Control · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903497041), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 5, 2020Terminated
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Z-0562-2021 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionJul 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH THE BD MULTI-CHECK CONTROL THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE R&D MULTI-CHECK CONTROLS (349701 AND 349704) COME DIRECTLY FROM R&D, THE 2D BARCODE CAN BE READ BY THE FACSDUET. BUT WHEN THE R&D CONTROLS ARE REPACKAGED FOR BDB THE QR BARCODE ON THE TUBE IS NOT COMPATIBLE WITH THE DUET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17359067 ↗
Other Mixture, hematology quality control devices
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- Research and Diagnostic Systems 3D503RXResearch And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- BD Trucount 340335Becton, Dickinson And Company · Mixture, hematology quality control1 recall0 reports
- Research and Diagnostic Systems 3D506USResearch And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D503Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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