Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
Reported: December 30, 2015 Initiated: November 19, 2015 #Z-0468-2016
Product Description
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: Domestic: 52 kits, Foreign: 623 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0468-2016.
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