Factor VIII Chromogenic Assay recall
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and…
Why was Factor VIII Chromogenic Assay recalled?
Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay.
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?
Lot Number 44637, exp. 2016-11-30
- Product
- Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- Domestic: 52 kits, Foreign: 623 kits
- Distribution
- Worldwide Distribution - US Distribution to the state of : Massachusetts and to the countries of : Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Serbia, Spain and Sweden.
- Recall date
- December 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)