BD Max" Ct/gc/tv recall
BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition…
Why was BD Max" Ct/gc/tv 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition…
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- N/A
- Distribution
- US and OUS.
- Recall date
- January 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)