Access Immunoassay Systems CORTISOL, Part Number: 33600

FDA device recall Z-2621-2010 · posted 2010-09-29 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I

Action taken

Two (2) Product Corrective Action (PCA) letters with attached Customer Response form were sent on the week of February 15, 2010 to the affected customers. The letters provide the customers with an explanation of the problem identified and instruct the customers to discontinue use of Access Progesterone and Access Cortisol Reagents, lot numbers referenced. For product replacements consignees were instructed : (1) In the United States, please contact Customer Service at 1-800-526-3821; (2) In Canada, please contact Customer Service at 1-800-463-7828; (3) Outside of the United States and Canada, contact your local Beckman Coulter Representative. If consignees need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.

Root cause

Other

Status

Terminated

Product code

CGR

Quantity affected

7282 units

Distribution

United States & Canada

Date initiated

2010-02-17

Date posted

2010-09-29

Date terminated

2012-04-19

Location

Brea, CA

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