# FDA recall Z-1552-2020

> **QUIDEL CARDIOVASCULAR INC** · Class II · device recall initiated 2019-04-09.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1552-2020
- **Recalling firm:** QUIDEL CARDIOVASCULAR INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-09
- **Report date:** 2020-04-01
- **Termination date:** 2021-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1552-2020

## Citation

> AI Analytics. FDA recall Z-1552-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1552-2020. Source: US FDA. Licensed CC0.

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