Influenza Transport Swab Packages, Reference #20171 recallZ-1231-2017 · Quidel Corporation · initiated Jan 25, 2017
Class II Terminated All recalls posted in February 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quidel Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.
FDA root cause category: Mixed-up of materials/components
What the company is doing
Quidel sent an Urgent Medical Device Recall letter dated 1/25/17 to all affected customers and distributors to inform them that Quidel is recalling the Influenza Transport Swab Packages because they may contain incorrect sample swab mixed in with the proper swabs. The letter informs the customers that the standard influenza swab is packaged individually, one (1) swab per package and uses a polyurethane foam tip. The incorrect swab is packaged as two (2) swabs per individual package and uses a rayon fiber tip. Customers are instructed to complete the enclosed Inventory Assessment/Certificate of Destruction form and return to Quidel. Contact Quidel Technical Support at [email protected] or by calling 800.874.1517 (in the U.S.), or 858.552.1100 (outside the U.S.), for instructions on how to obtain replacement product. Our hours of operation are Monday through Friday, 7:00 a.m. to 5:00 p.m. Pacific Time.
Recall details
- Recall number
- Z-1231-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 25, 2017
- Posted by the FDA
- Feb 22, 2017
- Recalling firm
- Quidel Corporation
- Quantity
- 1,010 packages
- Product code
- OCC
- FDA submissions
- K141520
- Distribution
- Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
Product description
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
Code information (models, lots, serial numbers)
PS10171
Other devices under the same FDA submission
3 devices cleared under K141520 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ID NOW™ Instrument EQ00200XAlere Scarborough, Inc. · Real Time Nucleic Acid Amplification System44 reports
- Alere™ i Instrument EQ00200XAlere Scarborough, Inc. · Real Time Nucleic Acid Amplification System5 reports
- Alere™ i Influenza A & B 425-024Alere Scarborough, Inc. · Respiratory Virus Panel Nucleic Acid Assay System1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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