Reported Nov 23, 2016 · Terminated
Dimension IRON Flex reagent cartridges
Siemens Healthcare Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension IRON Flex reagent cartridges
- Lot codes and dates
Device Listing # D011391 Lot # DB6267FD6309FB6310BA7006BB7006GB7060BA7116
- EC7200 Exp Date09/23/2016-0-7/19/2017
- Amount recalled
- 38,230 cartridges
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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