N/A 341099Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903410996), received between Jul 21, 2022 and Jul 21, 2022 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE BD CD5 PERCP-CY5.5 L17F12 ASR HAD ONE BOTTLE WITH NO LABEL OR MISSING LABEL INFORMATION (ALL REAGENT PACKAGING LEVELS). ADDITIONAL INFORMATION (B)(6)2022 THE EVENT TYPE ASSOCIATED WITH THIS COMPLAINT IS BEING USED WITH AN ASR REAGENT THAT IS FOR ASSAY SPECIFIC TESTING. SUN MIN LEE : (B)(6)2022 15:55:40 (GMT) (B)(6), BD SALES TEAM REPORTED AS BELOW. "(B)(6) AT THE UNIV OF KANSAS REPORTED YESTERDAY EVENING THAT ON PO-(B)(4), 1 BOTTLE OF ITEM # (B)(4) CAME WITH NO LABEL ON IT. WE CANNOT USE THIS. CAN BD PROVIDE A FOC REPLACEMENT? " THEY RECEIVED 41 QTY OF THIS LOT VIALS AND ONE BOTTLE CAME WITH NO LABEL. SENT ONE VIAL FOC OF THE SAME LOT: FOC PO# (B)(4). DELIVERY DATE WILL BE JULY 6TH DUE TO HOLIDAY SHIPPING SCHEDULE. SUN MIN LEE : (B)(6) 2022 15:52:14 (GMT). ONE BOTTLE OF THIS REAGENT CAME WITH NO LABEL ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076496 ↗