FDAFDA · Food and drugs·Recall number Z-1924-2013
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
Published August 14, 2013 · Recall initiated: July 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- USA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.
- Lot
- TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiration date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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