Siemens Recalls Dimension Vista IRON Flex Reagent Cartridges
Siemens Healthcare Diagnostics is recalling Dimension Vista IRON Flex reagent cartridges due to deferoxamine interference at concentrations not listed in the Instructions for Use.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which the rubric defines as unlikely to cause adverse health consequences. The issue is a discrepancy in interference data relative to the Instructions for Use, with no reported injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 30,247 units of Dimension Vista IRON Flex reagent cartridges. The recall was initiated because the company became aware of deferoxamine interference with the Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).
The affected products are distributed nationwide. The specific lot numbers involved are 15244AB, 15301BA, 15345BB, 16026BA, 16075BB, 16117BD, 16166BA, and 16201BD. The expiration dates for these units range from 07/19/2016 to 08-31-2016.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these units, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Dimension Vista IRON Flex reagent cartridges
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 30,247
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Device Listing # D011391 Lot # 15244AB
- 15301BA
- 15345BB
- 16026BA
- 16075BB
- 16117BD
- 16166BA
- 16201BD Exp Date 08-31-2016 - 07/19-2016.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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