Z-2135-2019 Class II Terminated
FDA device recall Z-2135-2019 was initiated by Siemens Healthcare Diagnostics Inc on May 29, 2019 and is designated Class II. Reason for recall: Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. The recall status is terminated (terminated May 12, 2022). Affected quantity: 2312.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- May 29, 2019
- Termination Date
- May 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2312
Product Description
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).
Reason for Recall
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019