Company: QUIDEL CARDIOVASCULAR INC
Date of Enforcement Report: 4/6/2020
Class II
PRODUCT
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 Number: Z-1552-2020
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.
RECALLING FIRM/MANUFACTURER
QUIDEL CARDIOVASCULAR INC on 4/9/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
123 kits
DISTRIBUTION
US Nationwide and International