CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
Quidel Triage TOX Drug Screen Control 1 Kit Box recalled
Quidel Cardiovascular is recalling Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with mL, distributed in 19 states. The recall was initiated on 9 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1552-2020
- FDA event ID
- 84698
- Recalling firm
- Quidel Cardiovascular, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2019
- FDA classified
- 20 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 9 Apr 2019 | Recall initiated by company | |
| 20 Mar 2020 | Classified by FDA | +346 days |
| 1 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US: ID, FL, GA, IL, TX, KY, MO, AL, UT, IA, WA, OH, AZ, NY, OK, OR, IN, KS Non-US: CA, NL
AlabamaArizonaCaliforniaFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyMissouriNew YorkOhioOklahomaOregonTexasUtahWashington
Questions about this recall
Is Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with mL recalled?
Yes. Quidel Cardiovascular recalled Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with mL on 9 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1552-2020.
Why was it recalled?
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.
Which lots are affected?
Lot Number: C3470AN Part Number 94413
Where was it sold?
US: ID, FL, GA, IL, TX, KY, MO, AL, UT, IA, WA, OH, AZ, NY, OK, OR, IN, KS Non-US: CA, NL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Quidel Cardiovascular
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Quidel Triage Cardiac Panel recalled by Quidel Cardiovascular | Quidel Cardiovascular | Other | 32 states |
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