Access Immunoassay Systems Thyroglobulin 의 리콜

Recall

57469

Class 2

Z-2215-2011

2010-10-18

2011-05-19

Terminated

United States

2012-08-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96293

The recall was initiated because in addition to access tg sample diluent, an additional diluent, access wash buffer ii, was added to thyroglobulin instructions for use (ifu) for evaluation of samples having tg levels above the reportable range of the assay. when customers interchange between diluents there is an unacceptable shift in results. a median difference of 16% (ranging from 14% to 23%) b.

The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 18, 2010, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems Thyroglobulin. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1. Do not dilute elevated thyroglobulin samples with Wash Buffer II. 2. Do not run thyroglobulin patient samples using the onboard dilution feature on the UniCel DxI instrument. 3. Dilute elevated thyroglobulin samples only with Access Thyroglobulin Sample Diluent (REF 33866). 4. Review your patient result archives. Manually dilute and repeat the analysis of all elevated thyroglobulin samples that had previously been diluted with Wash Buffer II, using Access Thyroglobulin Sample Diluent instead. 5. A forthcoming version of the UniCel DxI Assay Protocol File (APF) will remove the Access Thyroglobulin onboard dilution assay (dTg) from the list of available onboard dilution assays. 6. The Access Tg product Instructions for Use will be updated to eliminate Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. Customers should update procedure manuals and other documents that your laboratory may have created which list Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. In addition, customers were instructed to complete and return the enclosed PCA Response Form with in 10 days via fax to: 786-639-4000 or mail to: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. Customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman's Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact their local Be