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Recall Observatory FDA recall evidence

Device product

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

Z-1903-2021

May 10, 2021

Class II

Product summary

Firm
BioFire Diagnostics, LLC
Event
Event 87934
Status
Terminated
Classification
Class II
Quantity
870 kits
Official record key
device-enforcement:Z-1903-2021

Official wording

Reason: Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

Code information: Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338

Distribution pattern: US nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.