Reported Aug 7, 2019 · Terminated
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac…
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?
- Stratus CS Acute Care cTNI TestPak
- SMN 10445071 Product UsageIn vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI)
- Lot codes and dates
- Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019
- Amount recalled
- 2312
Where it was sold
- Nationwide
Why it was recalled
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
This product could cause temporary or reversible health problems — stop using it.
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