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U.S. Department of Health and Human Services

Class 2 Device Recall Triage TOX Drug Screen Control 1

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 Class 2 Device Recall Triage TOX Drug Screen Control 1see related information
Date Initiated by FirmApril 09, 2019
Create DateMarch 20, 2020
Recall Status1 Terminated 3 on January 14, 2021
Recall NumberZ-1552-2020
Recall Event ID 84698
510(K)NumberK060788 
Product Classification Drug mixture control materials - Product Code DIF
ProductQuidel 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
Code Information Lot Number: C3470AN Part Number 94413  
Recalling Firm/
Manufacturer		 QUIDEL CARDIOVASCULAR INC
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information ContactDawn Allenby
858-302-0227
Manufacturer 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 2		Software Manufacturing/Software Deployment
ActionOn 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
Quantity in Commerce123 kits
DistributionUS: ID, FL, GA, IL, TX, KY, MO, AL, UT, IA, WA, OH, AZ, NY, OK, OR, IN, KS Non-US: CA, NL
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DIF
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