Bd Max" Ct/Gc/Tv recallZ-0394-2018 · Becton Dickinson & Co. · initiated Jul 18, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Use error
What the company is doing
Customers were notified via UPS on 07/18/2017. The recall for BD MAX" Vaginal Panel and BD MAX" UVE Specimen Collection Kit was initiated on July 18, 2017 and expanded to include BD MAX" CT/GC/TV on August 11, 2017. The recall expansion letter to customers was dated 08/14/2017.
Recall details
- Recall number
- Z-0394-2018
- Status
- Terminated
- Initiated by the company
- Jul 18, 2017
- Recalling firm
- Becton Dickinson & Co.
- Product code
- NSU
- FDA submissions
- K151589
- Distribution
- US and OUS.
Product description
BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Code information (models, lots, serial numbers)
UDI: 30382904433766. All Lot numbers: All. All *.Catalog number 442970 was originally distributed in Europe only. Catalog number 443824 was discontinued and replaced with 442970 for US sales. Catalog number 442970 is now distributed worldwide. Not Distributed in US.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD MAX™ UVE Specimen Collection Kit 443376Becton, Dickinson And Company · Trichomonas vaginalis nucleic acid amplification test system3 recalls1 report
Other devices under the same FDA submission
1 device cleared under K151589 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BD MAX™ CT/GC/TV 442970Becton, Dickinson And Company · Trichomonas vaginalis nucleic acid amplification test system1 recall20 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 78808).
- Z-0392-2018 · TerminatedBD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of uri…
- Z-0393-2018 · TerminatedBD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine fr…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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