BD™ Multi-Check 340914Recalls & reported problems
Becton, Dickinson And Company · BD Multi-Check™ CD4 Low Ctrl 1X2.5mL IVD · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903409143), received between Aug 16, 2023 and Aug 29, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Wrong Label” (2 reports).
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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Wrong Label2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2023Wrong Label; Wrong Label
IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH BD MULTI-CHECK CD4 LOW CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTI-CHECK CD4 LOW CONTROL PRODUCT (#340914 BM0823L) BOX CONTAINS ANOTHER PRODUCT, MULTI-CHECK CONTROL (#340911; BM0823N) TUBE, SO COMPLAINTS ARE COMING IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17644382 ↗MalfunctionAug 16, 2023Wrong Label; Wrong Label
IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH BD MULTI-CHECK CD4 LOW CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTI-CHECK CD4 LOW CONTROL PRODUCT (#340914 BM0823L) BOX CONTAINS ANOTHER PRODUCT, MULTI-CHECK CONTROL (#340911; BM0823N) TUBE, SO COMPLAINTS ARE COMING IN. IT'S BEEN ALLEGED BY ONE OF OUR DISTRIBUTORS AND THE CONFIRMED Q¿TY WAS 5 BOXES. AND IT NEEDS TO CONFIRM WHETHER IT'S JUST A CORRECT PRODUCT (MULTI-CHECK CD4 LOW CONTROL (#340914; BM0823L)) WITH MISLABELED OR OTHER PRODUCTS(MULTI-CHECK CONTROL (#340911; BM0823N) PACKAGED. ALSO PLEASE NOTE THAT THE PRODUCT¿S EXPIRATION PERIOD IS JUST A MONTH, SO MANY CUSTOMERS ARE WORRIED ABOUT THEIR TESTING SCHEDULE, ESPECIALLY IN THE HOSPITALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17560797 ↗
Other Counter, differential cell devices
- Cytomics FC500 UPS (CXP)Beckman Coulter, Inc. · Counter, Differential Cell1,196 reports
- CELL-DYN 08H67-01Abbott Laboratories · Counter, differential cell6 recalls269 reports
- Alinity 09P6801Abbott Laboratories · Counter, differential cell2 recalls96 reports
- 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 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 · each recall links to the FDA recall notice
- 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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