Recall Z-1552-2020 ยท DIF Drug Mixture Control Materials
QUIDEL CARDIOVASCULAR INC
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
| Date | Apr 9, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| 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 CustomerNotifications@quidel.com. 5. If you have any |
| Quantity | 123 kits |
| Distribution | US: ID, FL, GA, IL, TX, KY, MO, AL, UT, IA, WA, OH, AZ, NY, OK, OR, IN, KS Non-US: CA, NL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 Biosite Incorporated, Jul 10, 2006 |