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FACS 349202Recalls & reported problems

Becton, Dickinson And Company · BD FACS™ Lysing Solution · 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 00382903492022), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

  • Device Markings/Labelling Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 13, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT INCORRECT LABEL INFORMATION WAS FOUND ON THE BD FACS LYSING SOLUTION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LABELING ISSUE (B)(4) FACSLYSING, CFDA CLASS I REGISTRATION AND CHINESE PRODUCT MANUAL SHOWS AS FORMALDEHYDE LESS THAN 10%. HOWEVER, CURRENT BOTTLE OUTSIDE LABEL WAS OUTDATED AND MISTAKEN, SHOWING FORMALDEHYDE LESS THAN 15%. IT SEEMS THE LABELS WERE NOT UPDATED AFTER CFDA CLASS I REGISTRATION AND PRODUCT MANUAL UPDATED IN EARLY 2019. AND CUSTOMERS ARE WORRIED ABOUT THE QUALITY AND FUNCTIONALITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

    MAUDE report 11167753 ↗

Other PRODUCTS, RED-CELL LYSING PRODUCTS devices

All PRODUCTS, RED-CELL LYSING PRODUCTS devices →

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