—#117953

Product

Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module

FDA product code: JMG — Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K963498
Affected lot / code info: Lot numbers RD23031, exp 2013-04-29; RD23111, exp 2013-05-07; RD23241, exp 2013-05-19; RD23311, exp 2013-06-04; and RD23461, exp 2013-06-11

Why it was recalled

Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an Urgent Medical Device Recall letter dated May 2013 to all affected customers. The letter identified the product and lots, the reason for the field action, the risk to health and the action(s) to be taken. Customers were instructed to discontinue use and discard inventory of the affected product. Siemens will replace any unused inventory of the affected lots at no charge. For questions contact your Siemens Technical Center or your local Siemens technical support representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: US Nationwide and OUS.

Timeline

Recall initiated: 2013-05-06
Posted by FDA: 2013-12-24
Terminated: 2014-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117953. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.