Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In 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).
- Recall Initiated
- May 29, 2019
- Terminated
- May 12, 2022
- Recall Number
- Z-2135-2019
- Quantity
- 2312
- Firm Location
- Norwood, MA
Reason for Recall
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Distribution
US Nationwide Distribution
Lot / Code Info
Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019
Root Cause
Under Investigation by firm
Action Taken
On May 29, 2019, Siemens issued Urgent Medical Device Correction notices to U.S.A. customers via FedEx courier service and Urgent Field Safety Notices to international customers via email. Actions to be Taken by the Customer: 1. Do not use TestPaks within 2 mos of expiration. 2. Repeat samples with cTNL results above 0.07 ng/mL or your institution's established 99th percentile value. 3. Complete and return the Field Correction Effectiveness Check form 4. Retain a copy of the letter with your laboratory records and forward a copy of the notice to anyone to whom you may have distributed the product. Siemens is working to resolve this issue and will contact customers when additional information is available. Siemens will reimburse users for repeat tests and discarded cTNL TestPaks within 2 months of the printed expiration date associated with this field corrective action.