BD MAX™ UVE Specimen Collection Kit 443376Recalls & reported problems

Becton, Dickinson And Company · BD MAX UVE Specimen Collection Kit · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30382904433766), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

3 FDA recall records name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K151589); they may or may not involve this specific model.

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.

Recalls naming this device

Jul 18, 2017Class IITerminated
BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
Z-0392-2018 · Root cause: Use error · Recall details · FDA record ↗
Jul 18, 2017Class IITerminated
BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
Z-0394-2018 · Root cause: Use error · Recall details · FDA record ↗
Jul 18, 2017Class IITerminated
BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
Z-0393-2018 · Root cause: Use error · Recall details · FDA record ↗

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.

MalfunctionJul 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ UVE SPECIMEN COLLECTION KIT INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CLIENT NOTES THAT THE EXPIRATION DATE IS DIFFERENT IN THE MEDIA FROM THE ONE REPORTED IN THE COLLECTION SWAB FROM THE ONE REPORTED ON THE PACKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12178034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151589. One submission often covers many models, so check the product and lot details in each record.

Z-2331-2019 · Jul 17, 2019 · Terminated
Kit BD Max CT/GC/TV; Catalog # 442970

Device details

UDI-DI	`30382904433766`
Brand	BD MAX™ UVE Specimen Collection Kit
Model	443376
Company	Becton, Dickinson And Company
Product code	OUY · Trichomonas vaginalis nucleic acid amplification test system
Class	Class 2
FDA submission	K151589
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jun 6, 2025

Device type (GMDN): Urogenital specimen collection kit IVD, clinical

A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower urogenital area (e.g., urethra) for in vitro diagnostic investigation [e.g., microbiological culture, histopathological cervical cancer screening]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium (e.g., preservative solution, Amies/Stuart transport medium); initial preparation/fixation/preservation materials may also be included in the kit. This is a single-use device.

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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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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