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
FDA Recall Z-1552-2020 · Posted None
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Recalling FirmQUIDEL CARDIOVASCULAR INC
Recall StatusTerminated
Product CodeDIF
Date Initiated2019-04-09
Date Terminated2021-01-14
Product Quantity123 kits
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.
Firm Action
On April 10, 2019 Quidel issued a recall notice to affected consignees to take the following actions:
1. Check the Quidel Triage TOX Drug Screen Control 1you have on hand to determine if you have any of the affected lot number (C3470AN).
2. If you locate the above-noted lot number, please properly destroy them to ensure they are not used.
3. If you have forwarded this lot to another facility, please forward this communication to that facility.
4. Complete the enclosed Inventory Assessment/Certificate of Destruction form and return to [email protected].
5. If you have any questions or require assistance, please contact Quidel Technical Support:
" For US and Canada, please call 800-874-1517, option 2
" For Europe and Middle East, please call +353 {91) 412 474
Root Cause
Software Manufacturing/Software Deployment
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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