—#98567

Product

Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems

FDA product code: CEC — Radioimmunoassay, Free Thyroxine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K982250
Affected lot / code info: Lot Numbers: 014769

Why it was recalled

The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met. The affected T4 calibrator lot can produce quality control and patient results that are erroneously low (by greater than 2 standard deviations). An erroneously low patient result may lead to misdiagnosis and/or delayed treatment.

Root cause (FDA determination)

Other

Action the firm took

The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter dated November 29, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: ACTION/RESOLUTION: " Discontinue use of Access Free T4 calibrator lot 014769. " Review historical quality control performance and determine whether any reported patient results were obtained while using a faulty calibration. If results were affected, you will see a shift downward in control recovery that produces out-of-range low QC results. " If patient results were obtained with Access Free T4 calibrator lot number 014769, it is possible they are erroneously low. If any patient results were reported in the period between the time the erroneous calibration with the affected lot was performed and when a different calibrator lot was used, the laboratory should consider advising physicians to whom results were reported so they can evaluate whether diagnosis or treatment decisions should be revisited. " No further orders of Access Free T4 Calibrator lot number 014769 will be shipped. Alternate lots will be provided for current and future replenishment orders or requests. Consignees/customers were asked to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed RESPONSE FORM via fax to Beckman Coulter at 786-639-4000. For product replacement: " In the United States, please contact Client Services at 1-800-526-3821, option 1. " In Canada, please contact Customer Service at 1-800-463-7828. " Outside of the United States and Canada, contact local Beckman Coulter representative. Questions and answers regarding this issue were enclosed for consignee/customer reference. Additional questions, were directed to the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customer

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide distribution: USA and countries including: Argentina, Belgium, Bosnia and Herzegovina, Canada, China, Colombia, Czech Republic, French Polynesia, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Oman, Panama, Philippines, Russian Federation, South Africa, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Venezuela, and Zambia.

Timeline

Recall initiated: 2010-11-11
Posted by FDA: 2011-04-11
Terminated: 2012-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98567. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.