medical Class II Updated 2020-04-01

QUIDEL CARDIOVASCULAR INC recalls Quidel Triage TOX Drug Screen Control 1 Kit Box containing

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: ID, FL, GA, IL, TX, KY, MO, AL, UT, IA, WA, OH, AZ, NY, OK, OR, IN, KS, CA
Lot/Code Info: Lot Number: C3470AN Part Number 94413
View official government recall

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