—#149809

Product

Dimension Vista IRON Flex reagent cartridges

FDA product code: JIY — Photometric Method, Iron (Non-Heme)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K060264
Affected lot / code info: Device Listing # D011391 Lot # 15244AB, 15301BA,15345BB,16026BA,16075BB,16117BD,16166BA,16201BD Exp Date 08-31-2016 - 07/19-2016.

Why it was recalled

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 (FDA determination)

Error in labeling

Action the firm took

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 IRON IFU's for Dimension and Dimension Vista products until the IFU's are updated.

Recalling firm

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

Distribution

Distribution pattern: Distributed Nationwide

Timeline

Recall initiated: 2016-08-25
Terminated: 2017-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.