CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report
STAT! 1- Panel Test Kit-mAMP recalled by Sarken
Sarken is recalling Sarken Stat! 1- Panel Test Kit-mAMP, 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
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-2052-2013
- 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
- Test Kits & Diagnostics
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! 1- Panel Test Kit-mAMP 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
Stores named: Walmart
Questions about this recall
Is STAT! 1- Panel Test Kit-mAMP recalled?
Yes. Sarken recalled STAT! 1- Panel Test Kit-mAMP on 29 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2052-2013.
Why was it recalled?
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.
Which lots are affected?
Manufacturer's Product Number DMA-114 Lot Number MET2100027 Expiration Date: 08/2014
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 |
|---|---|---|---|---|---|
| Device | CLASS II | STAT! 1- Panel Test Kit-OPI recalled by Sarken | Sarken | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | STAT! 1- Panel Test Kit-COC recalled by Sarken | Sarken | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | STAT! Multi-Drug Test Panel recalled by Sarken | Sarken | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | STAT! 1- Panel Test Kit-THC recalled by Sarken | Sarken | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | STAT! Multi-Drug Test Panel recalled by Sarken | Sarken | Lead & Heavy Metals | Nationwide |
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| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
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