Recall Z-0402-2017 ยท JIY Photometric Method, Iron (Non-Heme)
Siemens Healthcare Diagnostics, Inc.
Dimension IRON Flex reagent cartridges
| Date | Aug 25, 2016 |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU). |
| Root cause | Error in labeling |
| Action | Siemens mailed an Urgent Medical Device Correction letter to all customers who received the Dimension and Dimension Vista IRON Flex reagent with an update to the Limitation of Procedure section for the Dimension and Dimension Visa IRON assays Instructions For Use (IFU) to indicate that: patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. Customers were told that the information provided in the letter, related to deferoxamine, supersedes the information related to deferoxamine int he current |
| Quantity | 38,230 cartridges |
| Distribution | Distributed Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060264 | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) Dade Behring, Inc., Mar 8, 2006 |