FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1552-2020
- Recalling firm
- QUIDEL CARDIOVASCULAR INC
- 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
- Status
- Terminated
- Initiated
- 2019-04-09
- Posted
- not on file
- Terminated
- 2021-01-14
- 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 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
- 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
- Lot, serial or model codes
- Lot Number: C3470AN Part Number 94413
- 510(k) numbers
- ["K060788"]
- PMA numbers
- not on file
- Product code
- DIF
- Firm FEI
- 3013982035
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28