Recall Z-0401-2017
Siemens Healthcare Diagnostics, Inc. · initiated August 25, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Dimension Vista IRON Flex reagent cartridges
Codes / lots: Device Listing # D011391 Lot # 15244AB, 15301BA,15345BB,16026BA,16075BB,16117BD,16166BA,16201BD Exp Date 08-31-2016 - 07/19-2016.
Reason for recall
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).
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0401-2017
- Initiated
- August 25, 2016
- Terminated
- December 1, 2017
- Product code
- JIY – Photometric Method, Iron (Non-Heme)
- Quantity
- 30,247 units
- Distribution
- Distributed Nationwide
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0402-2017 Class III | Dimension IRON Flex reagent cartridgesSiemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension… | 08/25/2016Terminated |