Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an

FDA device recall Z-1924-2013 · posted 2013-08-07 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

Siemens sent an Urgent Medical Device Recall letter dated July 2013 to affected customers The letter identified the affected product, problem, potential risk, and actions to be taken by customers. Customers were requested to discuss the letter with thier laboratory director to determine if additional follow up is appropriate for patient tests conducted with the affected device lots. Additionally, customers were asked to discard any remaining inventory and to complete and return the field correction effectiveness check for replacement product. They were also asked to forward the letter to anyone wha had received this affected product. For questions contact your Siemens Technical Solutions Center or your local Siemens Technical support representative.

Root cause

Process control

Status

Terminated

Product code

MLM

Quantity affected

5423

Distribution

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.

Date initiated

2013-07-01

Date posted

2013-08-07

Date terminated

2014-08-26

Location

Newark, DE

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