Recall Z-1552-2020
Quidel Cardiovascular Inc · initiated April 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Number: C3470AN Part Number 94413
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.
FDA-determined cause: Software Manufacturing/Software Deployment
Action taken
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 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
Details
- Recall number
- Z-1552-2020
- Initiated
- April 9, 2019
- Terminated
- January 14, 2021
- Product code
- DIF – Drug Mixture Control Materials
- 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
- Recalling firm
- Quidel Cardiovascular Inc, San Diego, CA