CLASS II Device recall · Reported 1 Mar 2017 · FDA Enforcement Report

Influenza Transport Swab Packages, Reference #20171 recalled by Quidel

Quidel is recalling Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each, distributed nationwide in the US. The recall was initiated on 25 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPS10171

Quantity recalled1,010 packages

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1231-2017
FDA event ID: 76337
Recalling firm: Quidel, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2017
FDA classified: 22 Feb 2017
Reported: 1 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

25 Jan 2017	Recall initiated by company
22 Feb 2017	Classified by FDA	+28 days
1 Mar 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Florida Georgia Illinois Indiana Kentucky Montana Ohio Pennsylvania Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

PS10171

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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