Stratus CS Acute Care cTNI TestPak recall
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized…
Why was Stratus CS Acute Care cTNI TestPak recalled?
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019
- Product
- Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized…
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 2312
- Distribution
- US Nationwide Distribution
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)