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Recall Observatory FDA recall evidence

Device product

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

Z-1451-2020

August 08, 2019

Class II

Product summary

Firm
BioFire Diagnostics, LLC
Event
Event 84825
Status
Terminated
Classification
Class II
Quantity
23 kits (690 pouches)
Official record key
device-enforcement:Z-1451-2020

Official wording

Reason: 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.

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

Distribution pattern: US: KY, IL, NJ, MS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.