Dimension IRON Flex reagent cartridges recall
Dimension IRON Flex reagent cartridges
Why was Dimension IRON Flex reagent cartridges 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Listing # D011391 Lot # DB6267, FD6309, FB6310,BA7006,BB7006,GB7060,BA7116,EC7200 Exp Date: 09/23/2016-0-7/19/2017
- Product
- Dimension IRON Flex reagent cartridges
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 38,230 cartridges
- Distribution
- Distributed Nationwide
- Recall date
- November 23, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)