BioFire Diagnostics, LLC: Medical Device Recall in 2020 - (Recall #: Z-1451-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only

Product Classification:

Class II

Date Initiated: August 8, 2019

Date Posted: March 18, 2020

Recall Number: Z-1451-2020

Event ID: 84825

Reason for Recall:

Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.

Status: Terminated

Product Quantity: 23 kits (690 pouches)

Code Information:

Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30

Distribution Pattern:

US: KY, IL, NJ, MS

Voluntary or Mandated:

Voluntary: Firm initiated