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.
Reported: January 31, 2018 Initiated: July 18, 2017 #Z-0393-2018
Product Description
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.
Reason for 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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- N/A
- Distribution
- US and OUS.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Becton Dickinson & Co.. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2018. Severity: Moderate. Recall number: Z-0393-2018.
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