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N/A 656154Recalls & reported problems

Becton, Dickinson And Company · BD® CD81 (JS-81) APC-H7 · Class 1

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 00382906561541), received between Jul 14, 2020 and Jul 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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

  • Low Readings1

Patient problems

  • No Known Impact Or Consequence 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 14, 2020Low Readings; Low Readings

    IT WAS REPORTED THAT DURING USE THEY WERE LOSING APC CHANNEL RESOLUTION WITH A BD CD81 APC-H7 (JS-81) ASR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND TANDEM DYE DEGRADATION AFTER USING A PERIOD BEFORE EXPIRY DATE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10271029 ↗

Other Reagents, specific, analyte devices

All Reagents, specific, analyte devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.