FDA Device recall Z-1552-2020
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box by Quidel Cardiovascular, citing 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 M….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1552-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-09 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Quidel Cardiovascular |
| Distribution | AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS, KY, MO, NY, OH, OK, OR, TX, UT, WA |
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.
Identifiers
| code_info | Lot Number: C3470AN Part Number 94413 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1552-2020%22
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