CLASS II Device recall · Reported 16 Apr 2014 · FDA Enforcement Report

Morphine Strips (2000) recalled by LumiQuick Diagnostics

LumiQuick Diagnostics is recalling Morphine Strips (2000), 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

Lot, batch or date codesCatalog number: 74031, All lots

Quantity recalledALL

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-1386-2014
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: Other Medical Devices

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

Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054

Where it was distributed

Distributed in the states of CA, FL, NJ, TX, and NY.

California Florida New Jersey New York Texas

Questions about this recall

Is Morphine Strips (2000) recalled?

Yes. LumiQuick Diagnostics recalled Morphine Strips (2000) on 4 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1386-2014.

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: 74031, 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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