Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control… — Class II medical device recall Z-1552-2020
Terminated recall by QUIDEL CARDIOVASCULAR INC, reported 2020-04-01, distributed in AL, AZ, CA, FL, GA, IA, ID, IL…. Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropr
| Recall number | Z-1552-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QUIDEL CARDIOVASCULAR INC, San Diego, CA, United States |
| Recall initiated | 2019-04-09 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-01-14 |
| Distributed | AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS, KY, MO, NY, OH, OK, OR, TX, UT, WA |
| Quantity | 123 kits |
| Lot numbers | C3470AN |
| Model numbers | 94413 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1552-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.