BD MAX™ Enteric Bacterial Panel (US/CAN) 443378

• • Terminated Z-2330-2019 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-0981-2019 FDA Class II ·initiated 14 Jan 2019 ·on shared 510(k) K140111

  False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.

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

Trade Name

BD MAX™ Enteric Bacterial Panel (US/CAN)

Generic Name

Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Model / Ref / Catalog

443378

Primary DI / UDI-DI

00382904433789

510(k) Number

K140111 ↗

FDA Product Code

PCH, PCI, OOI

GMDN Term

Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Device Class

Class II

Regulation Number

866.3990, 862.2570

GUDID distribution status

Not in Commercial Distribution

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