BD Multi-Check™ 340912Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903409129), received between Dec 30, 2020 and Jul 26, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Readings” (2 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗