BD Leucocount™ 341002Recalls & reported problems
Becton, Dickinson And Company · Leucocount PLT Control Kit 25 Tests IVD · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00382903410026), received between Apr 16, 2021 and Apr 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
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.
MalfunctionApr 16, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT PRIOR TO USE WITH BD LEUCOCOUNT¿ THERE WAS A MIX OF PRODUCT. THE CUSTOMER RECEIVED BOXES OF PRODUCTS 341001 AND 341002, THE BOX OF 341002 CONTAINED VIALS FOR RBC CONTROL (SAME AS 341001). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: BD LEUCOCOUNT TM PLT CONTROL REF 341002 LOT LP0321 EXP 2021-05-05. DATA ON TUBES INNER PACKAGE: VIAL 1: BD LEUCOCOUNT TM RBC CONTROL HIGH RBC LOT LR0321H EXP 2021-05-05. VIAL 2: BD LEUCOCOUNT TM RBC CONTROL LOW RBC LOT LR0321L EXP 2021-05-05. OBSERVATIONS AND CONCLUSIONS - LOOKS LIKE A MISTAKE IN THE PACKAGING OF THE PRODUCT. THE CUSTOMER RECEIVED BOXES OF PRODUCTS 341001 AND 341002 AS DESCRIBED. IN CONTRAST, BOX 341002 CONTAINED VIALS FOR RBC CONTROL (SAME AS 341001).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11681745 ↗
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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
- 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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