BD MAX Vaginal Panel Recall: Unresolved Test Results Risk Repeat Testing
Becton Dickinson recalls BD MAX Vaginal Panel (catalogs 443712, 443710, 443711) due to increased unresolved and indeterminate test results, potentially requiring repeat testing.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Becton Dickinson is recalling its BD MAX Vaginal Panel because some tests show unresolved or indeterminate results, which may require repeating the test or re-collecting samples. This could lead to delays in diagnosis and treatment. Read more at govinfonow.com/recall/73399-bd-max-vaginal-panel-recall-unresolved-test-results-risk-repeat.
Source Summary by GovInfoNow · govinfonow.com/recall/73399-bd-max-vaginal-panel-recall-unresolved-test-results-risk-repeat · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0392-2018
Cite this page
“BD MAX Vaginal Panel Recall: Unresolved Test Results Risk Repeat Testing.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73399-bd-max-vaginal-panel-recall-unresolved-test-results-risk-repeat. Based on FDA recall #Z-0392-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0392-2018%22&limit=1).
Why it’s dangerous
The panel sometimes produces unresolved (UNR) or indeterminate (IND) results, meaning the test doesn't clearly indicate whether a condition is present. This could require repeating the test or re-collecting samples, causing delays in diagnosis.
Who’s affected
Healthcare providers using the BD MAX Vaginal Panel for vaginal and endocervical swab tests are affected. Patients who need this test may face delays in getting results.
How to tell if you have this one
Check for catalog numbers 443712, 443710, or 443711 on the panel. The product is for collection and transport of vaginal and endocervical swab specimens.
- Brand
Becton Dickinson- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US and OUS.
| Recall number | Product, codes & lots |
|---|---|
| Z-0392-2018 | BD 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 urine from males and females.; UDI: 30382904433766. All Lot numbers: Not Distributed in US Not Distributed in US |
| Z-0393-2018 | BD 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 from males and females.; UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970. |
| Z-0394-2018 | 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.; 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. |
What to do — step by step
Check Test Results
Review test results for unresolved (UNR) or indeterminate (IND) outcomes, which may require repeating the test.
How this recall unfolded
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0392-2018 (July 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0392-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.