Reported Jan 13, 2016 · Terminated

Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized…

Siemens Healthcare Diagnostics Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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 Dr · Norwood, MA · 02062-4637

Is this the product you have?

  • Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin
  • I in heparinized plasma Catalog NumberCCTNI
  • SMN10445071
Lot codes and dates
  • Lot Numbers
    • 235151002
    • 235159002
    • 235166002
    • 235173002
    • 235208002 235215002
    • 235222002
    • 235229002
    • 235236002
    • 235243002 235250002
    • 235257002
    • 235278002
    • 235285002
Amount recalled
5558

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide

Why it was recalled

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 23, 2016 · Data as of Sep 19, 6:01 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.