Bd Max™ CT/Gc/Tv 443824

• • Terminated Z-2331-2019 FDA Class II ·initiated 17 Jul 2019

  The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

• • Terminated Z-0394-2018 FDA Class II ·initiated 18 Jul 2017 ·on shared 510(k) K151589

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Bd Max™ CT/Gc/Tv

Generic Name

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Model / Ref / Catalog

443824

Primary DI / UDI-DI

00382904438241

510(k) Number

K151589 ↗

FDA Product Code

OUY

GMDN Term

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Device Class

Class II

Regulation Number

866.3860

GUDID distribution status

Not in Commercial Distribution

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