—#111723

Product

Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.

FDA product code: CDP — Radioimmunoassay, Total Triiodothyronine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K940833, K955435, K973966
Affected lot / code info: All Lots

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated: 2011-10-11
Posted by FDA: 2012-08-20
Terminated: 2013-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111723. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.