Recall Z-1552-2020— QUIDEL CARDIOVASCULAR INC
Class II · Terminated
Class II FDA medical device recall by QUIDEL CARDIOVASCULAR INC, initiated 2019-04-09, terminated 2021-01-14. It names one FDA 510(k) clearance: K060788. 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. 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
- QUIDEL CARDIOVASCULAR INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-09
- Terminated
- 2021-01-14
- 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
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.