CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report

STAT! Multi-Drug Test Panel recalled by Sarken

Sarken is recalling Sarken Stat! Multi-Drug Test Panel, distributed nationwide in the US. The recall was initiated on 29 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesManufacturer's Product Number HMO-W264 Lot Number F2290966 Expiration Date: 02/2014

Quantity recalledvarious quantities

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-2048-2013
FDA event ID: 65841
Recalling firm: Sarken, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 29 Jul 2013
FDA classified: 23 Aug 2013
Reported: 4 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

29 Jul 2013	Recall initiated by company
23 Aug 2013	Classified by FDA	+25 days
4 Sep 2013	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

These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

Where it was distributed

Worldwide Distribution - US Nationwide in the country Virgin Islands

Nationwide

Stores named: Walmart

Questions about this recall

Is STAT! Multi-Drug Test Panel recalled?

Yes. Sarken recalled STAT! Multi-Drug Test Panel on 29 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2048-2013.

Why was it recalled?

Which lots are affected?

Manufacturer's Product Number HMO-W264 Lot Number F2290966 Expiration Date: 02/2014

Where was it sold?

Worldwide Distribution - US Nationwide in the country Virgin Islands

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 Sarken

All 6

Reported	Class	Recall	Company	Reason	Where
4 Sep 2013Device	CLASS II	STAT! 1- Panel Test Kit-OPI recalled by Sarken	Sarken	Lead & Heavy Metals	Nationwide
4 Sep 2013Device	CLASS II	STAT! 1- Panel Test Kit-COC recalled by Sarken	Sarken	Lead & Heavy Metals	Nationwide
4 Sep 2013Device	CLASS II	STAT! Multi-Drug Test Panel recalled by Sarken	Sarken	Lead & Heavy Metals	Nationwide
4 Sep 2013Device	CLASS II	STAT! 1- Panel Test Kit-mAMP recalled by Sarken	Sarken	Lead & Heavy Metals	Nationwide
4 Sep 2013Device	CLASS II	STAT! 1- Panel Test Kit-THC recalled by Sarken	Sarken	Lead & Heavy Metals	Nationwide

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