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Recall Observatory FDA recall evidence

Device product

Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

Z-1231-2017

January 25, 2017

Class II

Product summary

Firm
Quidel Corporation
Event
Event 76337
Status
Terminated
Classification
Class II
Quantity
1,010 packages
Official record key
device-enforcement:Z-1231-2017

Official wording

Reason: Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.

Code information: PS10171

Distribution pattern: Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.