Recall Z-0561-2014 ยท JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
| Date | Dec 24, 2013 (initiated May 6, 2013) |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | 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. |
| Quantity | 17,719 |
| Distribution | US Nationwide and OUS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963498 | FERR FLEX REAGENT CARTRIDGE Dade Chemistry Systems, Inc., Jan 24, 1997 |