BD™ Universal Viral Transport for Viral, Specimens 220220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382902202203), received between Feb 1, 2022 and Feb 13, 2023 — classified as 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND FOREIGN MATTER IN THE MEDIA WHICH DISCOLORED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363038 ↗
• MalfunctionJul 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL THERE WAS A DISCREPANCY IN THE EXPIRATION DATE ON THE VIALS AND COC PACKAGING LIST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS A DISCREPANCY IN THE EXPIRATION DATE ON THE VIALS AND COC PACKAGING LIST. CUSTOMER PROBLEM: UVT 220220 LABELING ISSUE - DISCREPANCY IN EXP DATE ON VIALS AND COC / PACKING LIST. CUSTOMER RESPONDED PROVIDING 2 PHOTOS - PLEASE SEE ATTACHED, AND THE FOLLOWING RESPONSES: LOT NUMBER AND EXPIRATION DATE PRINTED ON THE VIALS; LOT N030681 EXPIRATION 2022-04-30. LOT NUMBER AND EXPIRATION DATE PRINTED ON THE PACKING LIST; LOT N030681 EXPIRATION 2022-05-31. SEE ALSO ATTACHED COFC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135695 ↗
• MalfunctionFeb 1, 2022False Negative Result; False Negative Result

  IT HAS BEEN REPORTED THAT THE BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL HAS BEEN FOUND PRODUCING A FALSE NEGATIVE RESULT. PCR WAS USED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, A FALSE NEGATIVE OCCURRED, POSSIBLY DUE TO THE PRODUCT. A PCR TEST WAS PERFORMED WITH AN ANTIGEN-POSITIVE SAMPLE. A NEGATIVE RESULT WAS GIVEN WITH A SAMPLE TRANSPORTED WITH UVT. POSITIVE RESULTS WERE GIVEN WHEN THE SAMPLE WAS STORED IN SALINE, AND WITH A MEASUREMENT OF SALIVA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417241 ↗