Z-0069-2012

Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges

Name: Z-0069-2012 Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2011-08-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-08-31 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges on 2011-08-31. The reason FDA records is "Firm has confirmed customer complaints for low recovery of QC and patient samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0069-2012
Status: Terminated
Initiated: 2011-08-31
Posted: 2011-10-19
Terminated: 2014-01-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Firm has confirmed customer complaints for low recovery of QC and patient samples.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.
Quantity in commerce: 6,072 cartons
Distribution: Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.
Product codes and lots: Lot Numbers ED2098, EA2111, FB2134, ED2147

Product code JJE

K081643Class IIDimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, Rf621, Kd692Siemens Healthcare Diagnostics / cleared 2008-07-03

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)