BD Multi-Check 349703Recalls & reported problems
Becton, Dickinson And Company · BD Multi-Check™ CD4 Low Control · Class 2
All models of BD Multi-Check (9)
Data updated Oct 16, 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 00382903497034), received between Oct 23, 2020 and Oct 23, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH A BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVD RESULTS SHOW EXTRA POPULATION IN LOW CONTROL. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING EXTRA POPULATION PRESENT IN LOW CONTROL ONLY. NORMAL CONTROL LOOKS AS EXPECTED. REQUIRES A GATE ADJUSTMENT TO CORRECT FOR THIS. CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT. QUALITY IS AWARE OF THIS ISSUE AND IS INVESTIGATING. ADDITIONALLY, ON 2020-10-07 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10726257 ↗
Other Mixture, hematology quality control devices
- BD Multi-Check 349704Becton, Dickinson And Company · Mixture, hematology quality control1 recall1 report
- Research and Diagnostic Systems D3D04Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D503RXResearch And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D501Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D507Research And Diagnostic Systems, Inc. · 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 D3D02Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- BD Trucount 340335Becton, Dickinson And Company · 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 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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