Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com

U.S. FDA — Device Enforcement · United States · 2019-04-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1552-2020
Date of alert
2019-04-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
QUIDEL CARDIOVASCULAR INC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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