Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyron

FDA device recall Z-2227-2012 · posted 2012-08-20 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.

Action taken

Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The PCA letter informed the customers of the problem identified and the actions to be taken. Customers were informed to stop SDA usage as an alternative dilutent and that the S0 dilutent is to be used for manual dilution of the patient sample for Total T3. They will also be informed to no longer use the On Board Dilution (OBD) option for Total T3. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding this notification were instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-961-4941.

Root cause

Device Design

Status

Terminated

Product code

CDP

Quantity affected

117,385 units total (33,918 units in US)

Distribution

Worldwide Distribution - USA (nationwide), Canada, and internationally.

Date initiated

2011-10-11

Date posted

2012-08-20

Date terminated

2013-03-14

Location

Brea, CA

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