Recall Z-1231-2017— Quidel Corporation
Class II · Terminated
Class II FDA medical device recall by Quidel Corporation, initiated 2017-01-25, terminated 2017-06-02. It names one FDA 510(k) clearance: K141520. 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. Reason: Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs..
- Recalling firm
- Quidel Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-25
- Terminated
- 2017-06-02
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.