N/A 641406Recalls & reported problems
Becton, Dickinson And Company · BD® CD3 (SK7) APC-H7 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382906414069), received between Jul 15, 2020 and Jul 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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.
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.
MalfunctionJul 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE AND PRIOR TO EXPIRATION THE ANTIBODIES ARE DEGRADING WITH A BD CD3 APC-H7 SK7 ASR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANTIBODIES DEGRADE THE CUSTOMER FOUND TANDEM DYE DEGRADATION AFTER USING A PERIOD BEFORE EXPIRY DATE. ADDITIONALLY, ON 2020-07-13, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THE REAGENT BEING USED IN A LAB DEVELOPED TEST FOR CLINICAL USE? YES. IF SO WAS THERE ANY IMPACT TO THE PATIENT? MAY MISINTERPRET THE DIAGNOSIS. DID SAMPLES NEED TO BE REDRAWN? NO. WAS THERE ANY DELAY IN TREATMENT? NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10275884 ↗
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- N/A 346587Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- CytoCell LPS508-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
- Vysis 05J70-001Abbott Molecular Inc. · REAGENTS,SPECIFIC,ANALYTE1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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