Z-1552-2020Class II

Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box...

Name: Z-1552-2020 Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box...
Creator: Quidel Cardiovascular Inc
Published: 2019-04-09
License: https://open.fda.gov/license/

Quidel Cardiovascular Inc. / initiated 2019-04-09 / Terminated / root cause: software

FDA source

QUIDEL CARDIOVASCULAR INC began a recall of 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... on 2019-04-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1552-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-09
Posted: 2020-03-20
Terminated: 2021-01-14
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
Product code: DIF Drug Mixture Control Materials
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.
Root cause tag: software
FDA 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 [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
Quantity in commerce: 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
Product codes and lots: Lot Number: C3470AN Part Number 94413

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1552-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1552-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code DIF

K060788Class ITriage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated / cleared 2006-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)