BD Multitest 340499Recalls & reported problems
Becton, Dickinson And Company · Multitest CD3/CD8/CD45/CD4 50 Tests IVD · Class 2
- 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 00382903404995), received between Jul 29, 2021 and Jul 29, 2021 — 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 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 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE RUNNING PATIENT SAMPLE WITH BD MULTITEST¿THERE WAS ABNORMAL BEHAVIOR IN STAINING. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE USER INDICATES THAT WHEN THE SAMPLE IS ACQUIRED IN THE GRAPHS THE GRANULOCYTE POPULATION IS NOT SHOWN. REMOTE ASSISTANCE WAS PERFORMED TO REVIEW THE SAMPLE ACQUISITION READINGS. THE READINGS WERE MADE WITH THE MULTITEST REAGENT WITH LOT NUMBER: 43889. THE REPORTS WITH THIS LOT SHOWED AN ABNORMAL BEHAVIOR IN THE STAINING. SAMPLES WERE STAINED WITH A DIFFERENT LOT OF REAGENT, WHICH CORRECTED THESE READINGS. ANNEX EVIDENCE AND REAGENT LOT NUMBER. -TYPE OF SAMPLES: PATIENTS: -NO RESULTS WERE ISSUED TO THE PATIENT SINCE IT WAS DETECTED AT THE TIME OF ANALYSIS. IT DID NOT AFFECT TREATMENT, THERE WERE NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12248395 ↗
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- FACSCanto 338960Becton, Dickinson And Company · Counter, differential cell1 recall117 reports
- Cytomics FC500 UPS (MPL)Beckman Coulter, Inc. · Counter, Differential Cell141 reports
- CELL-DYN 08H00-01Abbott Laboratories · Counter, differential cell1 recall90 reports
- CELL-DYN 09H39-01Abbott Laboratories · Counter, differential cell123 reports
- BD Multitest 662995Becton, Dickinson And Company · Counter, differential cell2 recalls1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.