Z-2407-2010

Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark...

Name: Z-2407-2010 Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-06-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-06-15 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware on 2010-06-15. The reason FDA records is "Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2407-2010
Status: Terminated
Initiated: 2010-06-15
Posted: 2010-09-13
Terminated: 2010-12-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.
Product code: MLM Enzyme Immunoassay, Tracrolimus
Reason for recall: Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.
FDA root cause: Other
Action: Siemens issued an "Urgent Field Safety Notice" dated June, 2010 to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the TACR Flex reagent lots DC0306, CA0320, DA0334 and GA0348. The letter contains the following instructions: 1) Immediately discontinue use of the affected lots; 2) Discard all remaining inventory of the affected lots; 3) Contact Siemens Healthcare Diagnostics Technical Solutions Center for replacement product; 4) Complete and return the Field Correction Effectiveness Check by fax to 302 631-8467; 4) Siemens is recommending that the content of the letter should be discussed with the laboratory director. If unexpectedly low results are obtained on a patient sample, caution should be exercised before decisions regarding therapeutic dosage adjustments are made. As stated in the package insert, "Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. Also individual tacrolimus values cannot be used as the sole indicator for making changes in the treatment regimen. Each patient should be thoroughly evaluated clinically before treatment adjustments are made." Siemens Technical Solutions Center may be contacted at 800-441-9250
Quantity in commerce: 4580 Cartons
Distribution: Worldwide Distribution to USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, LA, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI, and countries of Austria, Belgium, Canary Islands, Egypt, France, Germany, Great Britain, Hungary, Italy, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, United Arab Emirates, Argentina, Brazil, Canada, Columbia, El Salvador, Venezuela, Australia, Hong Kong, India, Japan, Malaysia, New Zealand, South Korea, Singapore, Taiwan and China.
Product codes and lots: Lot Numbers: DC0306 (exp 11/2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10), GA0348 (exp 12/14/10)

Product code MLM

K060502Class IIDimension Tacr Flex Reagent Cartridge, Model Df107Dade Behring, Inc. / cleared 2006-05-18

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)