Siemens Recalls Dimension IRON Flex Reagent Cartridges Due to Interference
Siemens Healthcare Diagnostics is recalling Dimension IRON Flex reagent cartridges because deferoxamine interferes with the assay at a different concentration than listed in the instructions.
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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 38,230 Dimension IRON Flex reagent cartridges. The recall was initiated because the company became aware of deferoxamine interference with the Dimension and Dimension Vista IRON assays. This interference occurs at a different concentration than what is listed in the Instructions for Use (IFU).
The affected product is distributed nationwide. The specific lot numbers involved are DB6267, FD6309, FB6310, BA7006, BB7006, GB7060, BA7116, and EC7200. The expiration dates for these cartridges range from 09/23/2016 to 07/19/2017. The device listing number is D011391.
This recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences. Users should stop using the affected cartridges and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension IRON Flex reagent cartridges
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 38,230
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 # DB6267
- FD6309
- FB6310
- BA7006
- BB7006
- GB7060
- BA7116
- EC7200 Exp Date: 09/23/2016-0-7/19/2017
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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