Device Recall Access Thyroglobulin Antibody II, Part Number: A32898 의 리콜

Recall

57946

Class 2

Z-1818-2011

2011-01-26

2011-03-24

Terminated

United States

2012-05-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97800

The recall was initiated after beckman coulter confirmed customer reports of reagent pack to pack variability for the access thyroglobulin antibody ii (tgab) reagent lot numbers identified in the recall. erroneous results for patient and quality control samples can be generated. the thyroglobulin antibody ii (tgabii) reagent lots may produce: (1) erroneously high tgab results for both quality co.

Beckman Coulter sent a Product Corrective Action (PCA) letter on January 26, 2011 via US Postal Service to the affected customers. The letter explained the problem identified and the action to be taken. Customers were instructed to: (1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers identified in the table above; (2) If customers obtained questionable thyroglobulin antibody results, or received feedback from clinicians on reported thyroglobulin antibody results using the reagent lot numbers identified above, rerun or request a redraw of the patient sample; (3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they should provide a copy of the letter to them; (4) Complete and return the enclosed response form within 10 days so the firm can be assured that you have received this important notification and are taking appropriate action. For questions regarding the recall communication, customers were told to contact Beckman Coulter Customer Support Center: (1) Via our website, http://www.beckmancoulter.com/customersupport/support (2) Via phone, call 1-800-854-3633 in the United States and Canada (3) Outside the United States and Canada please contact your local Beckman Coulter representative.