—#101937

Product

Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.

FDA product code: KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K023369
Affected lot / code info: Lot Number: 917074, 008534 Expiration Date: 917074 (12/31/10), 008534 (2/28/11)

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests. Customers with questions regarding this notification can call Technical Support at (800) 854-3633 or contact their local Beckman Coulter representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Canada.

Timeline

Recall initiated: 2010-08-26
Posted by FDA: 2011-08-16
Terminated: 2012-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.