Z-0038-2012

Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro...

Name: Z-0038-2012 Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro...
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 Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac... on 2011-08-31. The reason FDA records is "Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an...". 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-0038-2012
Status: Terminated
Initiated: 2011-08-31
Posted: 2011-10-12
Terminated: 2013-05-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient and QC results may be observed.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Siemens sent an Urgent Field Safety Notice dated August 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard any remaining inventory. Replacement orders would be processed and sent free of charge. Customers were also instructed to complete the attached FIELD CORRECTION EFFECTIVENESS CHECK form and fax it to (302) 631- 8457. Customers were instructed to forward the Safety Notice to anyone to whom they may have distributed the affected product. For any technical questions customers were to contact the Siemens Solutions Center at 800-441-9250.
Quantity in commerce: 998
Distribution: Worldwide Distribution - USA (nationwide) including AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of GUAM, Austria, Canada, China, Czech Republic, Egypt, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain and Switzerland.
Product codes and lots: Lot Number 1AD045

Product code JJE

K081683Class IILoci Cardiac Troponin I Calibrator, Model Rc621Siemens Healthcare Diagnostics / cleared 2008-07-07

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)