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U.S. Department of Health and Human Services

Class 2 Device Recall Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes

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  Class 2 Device Recall Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes see related information
Date Initiated by Firm April 22, 2016
Create Date May 25, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-1720-2016
Recall Event ID 73949
510(K)Number K940401  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Code Information Lot #B6JCA012
Recalling Firm/
Manufacturer		 Accriva Diagnostics Inc., dba ITC, dba Accumetrics
6260 Sequence Dr
San Diego CA 92121-4358
Manufacturer Reason
for Recall		 Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
FDA Determined
Cause 2		 Process design
Action Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvettes, with the subject Lot Number destroy the product and submit the attached Destruction Form along with your request for credit. 4. If have inventory DO NOT SHIP TO CUSTOMERS any kits labeled with APTT Test Cuvettes and the subject Lot Number. 5. If have shipped this product to customers please inform them immediately to STOP using the product. Provide the customers with a copy of this notification, request for the destruction of any unused product and the return of the attached forms. 6. Follow the instructions on the attached Field Corrective Action Form, complete the form and return it as instructed on the form. 7. If have questions, please contact Accriva Diagnostics directly contact information is provided below. Accriva Diagnostic, Attn: Regulatory Affairs USA Tel: 858.263.2347 Email: Fieldaction16-007@accriva.com
Quantity in Commerce 135 boxes
Distribution U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
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 = JPA and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
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