QUIDEL CARDIOVASCULAR INC: Medical Device Recall in 2020 - (Recall #: Z-1552-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 9, 2019

Date Posted: April 1, 2020

Recall Number: Z-1552-2020

Event ID: 84698

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.

Status: Terminated

Product Quantity: 123 kits

Code Information:

Lot Number: C3470AN Part Number 94413

Distribution Pattern:

US: ID, FL, GA, IL, TX, KY, MO, AL, UT, IA, WA, OH, AZ, NY, OK, OR, IN, KS Non-US: CA, NL

Voluntary or Mandated:

Voluntary: Firm initiated