Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes 의 리콜

Recall

73949

Class 2

Z-1720-2016

2016-04-22

Terminated

United States

2016-12-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145590

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.

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