Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitat

FDA device recall Z-0517-2014 · posted 2013-12-16 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

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.

Root cause

Component design/selection

Status

Terminated

Product code

MLM

Quantity affected

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.

Date initiated

2013-04-25

Date posted

2013-12-16

Date terminated

2014-11-12

Location

Newark, DE