—#92314

Product

Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K042651
Affected lot / code info: Lot #'s: 989902, 989903, 989904, 989905, 989906 & 989907

Why it was recalled

Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Beckman Coulter sent a letter dated December 29, 2009, providing the customers with an explanation of the reason for recall and asked them to take the following actions: - Discontinue use of the lots of reagent listed above. - Review your historical quality control to ensure that the assay performance of these lots has been within your laboratory specifications. NOTE: Out-of-range high quality control results may indicate invalid test results. Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed response form within 10 days so that Beckman can be assured that they received this important notification. Assistance or questions regarding this notification, were directed to Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.

Recalling firm

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

Distribution

Distribution pattern: Distribution Nationwide and Canada.

Timeline

Recall initiated: 2009-12-17
Posted by FDA: 2011-05-10
Terminated: 2012-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92314. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.