CLASS II Device recall · Reported 16 Apr 2014 · FDA Enforcement Report
Fentanyl Test Strip recalled by LumiQuick Diagnostics
LumiQuick Diagnostics is recalling Fentanyl Test Strip, distributed in California, Florida, New Jersey, New York, Texas. The recall was initiated on 4 Mar 2014 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-1403-2014
- FDA event ID
- 67665
- Recalling firm
- LumiQuick Diagnostics, Santa Clara, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2014
- FDA classified
- 7 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 4 Mar 2014 | Recall initiated by company | |
| 7 Apr 2014 | Classified by FDA | +34 days |
| 16 Apr 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product as listed by the FDA
Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054
Where it was distributed
Distributed in the states of CA, FL, NJ, TX, and NY.
Questions about this recall
Is Fentanyl Test Strip recalled?
Yes. LumiQuick Diagnostics recalled Fentanyl Test Strip on 4 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1403-2014.
Why was it recalled?
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Which lots are affected?
Catalog number: 74057, All lots
Where was it sold?
Distributed in the states of CA, FL, NJ, TX, and NY.
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.
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| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |