BD Multi-CheckRecalls & reported problems across all models
Becton, Dickinson And Company · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 9 models of BD Multi-Check by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2020 and Aug 29, 2023 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (6 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
BD Multi-Check recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 6 of these models · Recall details · FDA record ↗
Most reported BD Multi-Check problems
Device problems
- Device Markings/Labelling Problem6
- Incorrect, Inadequate or Imprecise Result or Readings3
- Low Readings2
- Wrong Label2
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient3
BD Multi-Check models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD™ Multi-Check 340914Counter, differential cell1 recall2 reports
- BD Multi-Check 349703Mixture, hematology quality control1 recall1 report
- BD Multi-Check 349704Mixture, hematology quality control1 recall1 report
- BD™ Multi-Check 340915Counter, differential cell1 recall0 reports
- BD™ Multi-Check 340916Counter, differential cell1 recall0 reports
- BD Multi-Check 349705Mixture, hematology quality control1 recall0 reports
- BD Multi-Check™ 340911Counter, differential cell5 reports
- BD Multi-Check™ 340912Counter, differential cell4 reports
- BD Multi-Check 349701Mixture, hematology quality control1 report
Recent BD Multi-Check adverse event reports
The 14 most recent reports across all models, 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 ↗MalfunctionJul 26, 2023Missing Information; Missing Information
IT WAS REPORTED THAT THE LABEL WAS MISSING FROM THE BD MULTI-CHECK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO REFERENCE VALUES PROVIDED NO ASSAY VALUES AND EXPECTED RANGES WERE PROVIDED WITH THE PRODUCT, CUSTOMER IS ASKING FOR THESE. COULD YOU PLEASE CLARIFY IF PART OF THE LABEL WAS MISSING OR IF THE INFORMATION IS INCORRECT ON THE LABEL? YES THAT IS CORRECT, THIS WAS MISSING FROM THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17401273 ↗MalfunctionJul 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH THE BD MULTI-CHECK CONTROL THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE R&D MULTI-CHECK CONTROLS (349701 AND 349704) COME DIRECTLY FROM R&D, THE 2D BARCODE CAN BE READ BY THE FACSDUET. BUT WHEN THE R&D CONTROLS ARE REPACKAGED FOR BDB THE QR BARCODE ON THE TUBE IS NOT COMPATIBLE WITH THE DUET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17359069 ↗MalfunctionJul 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH THE BD MULTI-CHECK CONTROL THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE R&D MULTI-CHECK CONTROLS (349701 AND 349704) COME DIRECTLY FROM R&D, THE 2D BARCODE CAN BE READ BY THE FACSDUET. BUT WHEN THE R&D CONTROLS ARE REPACKAGED FOR BDB THE QR BARCODE ON THE TUBE IS NOT COMPATIBLE WITH THE DUET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17359067 ↗MalfunctionMay 22, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHILE USING BD MULTI-CHECK¿ THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAS BEEN A CHANGE TO THE REFERENCE RANGE PRODUCT INSERT AND THE RUO RANGE VALUES ARE NO LONGER PROVIDED. THE CUSTOMER HAS NOT BEEN INFORMED OF THIS CHANGE WHICH IMPACTS THEIR PROCESS AND SOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16979438 ↗MalfunctionMay 22, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHILE USING THE BD MULTI-CHECK¿ THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAS BEEN A CHANGE TO THE REFERENCE RANGE PRODUCT INSERT AND THE RUO RANGE VALUES ARE NO LONGER PROVIDED. THE CUSTOMER HAS NOT BEEN INFORMED OF THIS CHANGE WHICH IMPACTS THEIR PROCESS AND SOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16979436 ↗MalfunctionMay 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHILE USING THE BD MULTI-CHECK¿ THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAY BATCH BM0523N ASSAY VALUES SHEET IS MISSING VALUES FOR ALL MARKERS EXCEPT TBNK. CANNOT BE USED TO VALIDATE LABORATORY ANTIBODY PERFORMANCE, HENCE UNABLE TO VALIDATE RESULTS FOR PATIENT REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16876777 ↗MalfunctionDec 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHILE USING THE BD¿ MULTI-CHECK THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:TUBE HAS NO LABEL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16064713 ↗MalfunctionApr 16, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHEN OPENING BD¿ MULTI-CHECK PACKAGE, THE PRODUCT LISTED WAS PART # 557940. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN OPENING THE PACKAGE, THE REFERENCE 557940 WAS IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11681900 ↗MalfunctionMar 31, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THE PACKAGE INSERT FOR BD¿ MULTI-CHECK HAS INCORRECT MEAN VALUE FOR % TOTAL FOR CD3+CD4+, OR THE RANGE IS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE LOTSPECIFIC ASSAY VALUES AND EXPECTED RANGES PACKAGE INSERT ONE OF THE VALUES FOR % TOTAL FOR CD3+CD4+ THE MEAN VALUE OF 50,4 % IS NOT CORRECT, SHOULD BE 51,9% OR THE RANGE OF 43,9-59,9 IS NOT CORRECT. CUSTOMER USE BD MULTI-CHECK CONTROL CAT NO #340912 AND THE BD MULTI-CHECK CD4 LOW CONTROL, CAT NO #340915. FOR THE CD4 LOW CONTROL THE VALUES ARE CORRECT. PLEASE CHECK THE VALUES FOR THE NORMAL CONTROL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11595041 ↗MalfunctionDec 30, 2020Low Readings; Low Readings
IT WAS REPORTED THAT WHILE USING BD MULTI-CHECK CONTROL 2X2.5ML IVD THE CD4 EVENTS ARE NOT WITH IN RANGE. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS REPORTING THE % OF CD4 EVENTS IS NOT WITHIN THE RANGES STATED FOR THIS LOT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11098674 ↗MalfunctionDec 30, 2020Low Readings; Low Readings
IT WAS REPORTED THAT WHILE USING BD MULTI-CHECK CONTROL 2X2.5ML IVD THE CD4 EVENTS ARE NOT WITHIN RANGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS REPORTING THE % OF CD4 EVENTS IS NOT WITHIN THE RANGES STATED FOR THIS LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11098494 ↗MalfunctionOct 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH A BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVD RESULTS SHOW EXTRA POPULATION IN LOW CONTROL. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING EXTRA POPULATION PRESENT IN LOW CONTROL ONLY. NORMAL CONTROL LOOKS AS EXPECTED. REQUIRES A GATE ADJUSTMENT TO CORRECT FOR THIS. CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT. QUALITY IS AWARE OF THIS ISSUE AND IS INVESTIGATING. ADDITIONALLY, ON 2020-10-07 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10726257 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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