Z-2135-2019Class II

Stratus CS Acute Care cTNI TestPak, SMN 10445071

Name: Z-2135-2019 Stratus CS Acute Care cTNI TestPak, SMN 10445071
Creator: Siemens Healthcare Diagnostics Inc
Published: 2019-05-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-05-29 / Terminated

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma... on 2019-05-29. FDA classified it as Class II and gives the reason as "Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2135-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Posted: 2019-07-30
Terminated: 2022-05-12
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).
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
FDA 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 in commerce: 2312
Distribution: US Nationwide Distribution
Product codes and lots: Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2135-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2135-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30

Product code MMI

K051650Class IIStratus Cs Acute Care Mb Isoenzyme of Creatine Kinase (Ckmb) Test Pak; Stratus Cs Acute Care Ckmb Testpak.Dade Behring, Inc. / cleared 2005-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)