Reported May 14, 2014 · Terminated

CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

Siemens Healthcare Diagnostics Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Drive · Norwood, MA · 02062

Is this the product you have?

  • CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Lot codes and dates
  • Serial Number212809
Amount recalled
1 unit

Where it was sold

Why it was recalled

Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 6, 2014 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.