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

FDA device recall Z-2178-2011 · posted 2011-05-10 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JIT

Quantity affected

2,320 kits

Distribution

Distribution Nationwide and Canada.

Date initiated

2009-12-17

Date posted

2011-05-10

Date terminated

2012-03-29

Location

Brea, CA

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