Recall Z-0517-2014
Siemens Healthcare Diagnostics, Inc. · initiated April 25, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients
Codes / lots: Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267.
Reason for recall
Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
FDA-determined cause: Component design/selection
Action taken
Siemens sent an Urgent Medical Device Correction letter dated April 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A recall notification letter was sent to consignees in April 2013. Customers using the affected product should load Flex reagent cartridges on board immediately prior to use and remove the Flex after 8 hours. Do not load more Flexes than the lab will use in 8 hours and do not pre-hydrate TACR Flexes. Customers were asked to complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at 302-631-8467. Customers were asked to forward the communication to anyone to whom may have distributed the product. Customers with questions were instructed to contact the Siemens Technical Solutions Center or their local Siemens technial support representative. For questions regarding this recall call 800-441-9250.
Details
- Recall number
- Z-0517-2014
- Initiated
- April 25, 2013
- Posted by FDA
- December 16, 2013
- Terminated
- November 12, 2014
- Product code
- MLM – Enzyme Immunoassay, Tracrolimus
- Quantity
- 13,751
- Distribution
- Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE