Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic par

FDA device recall Z-3023-2011 · posted 2011-08-15 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CGI

Quantity affected

2786 units total (2776 in the US)

Distribution

Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada.

Date initiated

2009-12-08

Date posted

2011-08-15

Date terminated

2012-04-16

Location

Brea, CA