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BD Multi-Check™ 340911Recalls & reported problems

Becton, Dickinson And Company · BD Multi-Check™ Control 1X2.5mL IVD · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903409112), received between Apr 16, 2021 and May 22, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 reports).

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 Problem5

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • 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 ↗

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