Device Recall Siemens Factor VIII Chromogenic Assay 의 리콜

Recall

72752

Class 2

Z-0468-2016

2015-11-19

2015-12-22

Terminated

United States

2017-08-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142132

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.

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 letter within 30 days. - Review your inventory of this product to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Corrective Action: The Factor VIII Chromogenic Assay Lot Number 44637 kits were placed on product hold on August 19, 2015, at the Siemens Distribution Centers. For further questions, please call ( 914) 524 - 2495.