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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Factor VIII Chromogenic Assay

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  Class 2 Device Recall Siemens Factor VIII Chromogenic Assay see related information
Date Initiated by Firm November 19, 2015
Date Posted December 22, 2015
Recall Status1 Terminated 3 on August 15, 2017
Recall Number Z-0468-2016
Recall Event ID 72752
510(K)Number K884544  
Product Classification Test, qualitative and quantitative factor deficiency - Product Code GGP
Product Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
Code Information Lot Number 44637, exp. 2016-11-30
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ms. Elizabeth Bernasconi
914-524-2495
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GGP and Original Applicant = BAXTER HEALTHCARE CORP.
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