FDA Enforcement
Class II
Terminated
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
Recall: Z-1552-2020
·
Reported April 1, 2020
Enforcement
- Recall Number
- Z-1552-2020
- Event ID
- 84698
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- QUIDEL CARDIOVASCULAR INC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2020
- Initiation Date
- April 9, 2019
- Classification Date
- March 20, 2020
- Termination Date
- January 14, 2021
- Address
- 9975 Summers Ridge Rd, N/A, San Diego, CA, 92121-2997, United States
Description
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
Reason
Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.
Code Info
Lot Number: C3470AN Part Number 94413
Distribution
US: ID, FL, GA, IL, TX, KY, MO, AL, UT, IA, WA, OH, AZ, NY, OK, OR, IN, KS Non-US: CA, NL
Quantity
123 kits