FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: 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 number
- Z-2135-2019
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- 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).
- Status
- Terminated
- Initiated
- 2019-05-29
- Posted
- not on file
- Terminated
- 2022-05-12
- Reason
- Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 2312
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019
- 510(k) numbers
- ["K051650"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28