Recall Z-0468-2016 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Siemens Healthcare Diagnostics, Inc.
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
| Date | Dec 22, 2015 (initiated Nov 19, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | Siemens sent an Urgent Medical Device Correction Letter dated November 19, 2015, to all affected customers . The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by Customers: If you are using the affected lot of Factor VIII Chromogenic Assay on a Sysmex CA-1500 or CA-7000 System, please discontinue use. - Due to a different detection principle, the use on BCS and BCS XP is not affected and you can continue using the product on BCS / BCS XP. - Complete and return the Field Correction Effectiveness Check attached to this lette |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884544 | DADE FACTOR VIII CHROMOGENIC ASSAY Baxter Healthcare Corp, Dec 30, 1988 |