Device Recall Access Immunoassay Systems Unconjugated Estriol 의 리콜

Recall

59235

Class 2

Z-3023-2011

2009-12-08

2011-08-15

Terminated

United States

2012-04-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101912

The recall was initiated because beckman coulter has confirmed customer reports that a single lot of access unconjugated estriol reagent (pin 33570) may produce suppressed patient results and an increased incidence of ind (indeterminate) flags. these issues have been associated with reagent lot 913348. this reagent met all testing specifications prior to release.

Beckman Coulter sent a PRODUCT CORRECTIVE ACTION (PCA) letter dated December 8, 2009, to all affected customers. The letter was sent via US Postal Service for all US customers with attached PCA response form. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of Access Unconjugated Estriol reagent lot number 913348. " No further orders of Access Unconjugated Estriol reagent lot number 913348 will be shipped. " Abnormally low Access Unconjugated Estriol results from samples tested previously with the affected lot should be reviewed in the context of other diagnostic tests. " Access Unconjugated Estriol results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. Rerun any tests that produce a questionable result. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at (800) 854-3633 in the US and Canada. Outside of Canada and the US, customers were instructed to contact their local Beckman Coulter Representative.