Recall – Diagnostic immunoassay meter incorrectly displays failing result

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

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