Z-0876-06

Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic

Name: Z-0876-06 Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic
Creator: Dade Behring , Inc.
Published: 2006-04-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-04-03 / Terminated

FDA source

Dade Behring , Inc. began a recall of Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic on 2006-04-03. The reason FDA records is "Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0876-06
Status: Terminated
Initiated: 2006-04-03
Posted: 2006-05-19
Terminated: 2006-08-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
FDA root cause: Other
Action: Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.
Quantity in commerce: 10843 cartons of 100 TestPaks
Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
Product codes and lots: Lot # 235276002; 235283002; 235290002; 235297002; 235304002; 235311002, 235318002; 235325002; 235338002; 235339002; 235346002; 235353002; 235361002; 236009002; 236016002; 236023002; 236030002; 236037002; 236044002; 236051002; 236058002; 236065002; 236072002; and 236079002.

Product code MMI

K033487Class IIStratus Cs Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. / cleared 2003-12-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)