Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemilumines

FDA device recall Z-1396-2009 · posted 2009-05-22 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal tes

Action taken

An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to: (1) Share this information with their laboratory staff and retain the letter for their Quality System documentation, (2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coulter, Inc. can be assured that the customer received the notification, and (3) Contact Customer Technical Support at 1-800-854-3633 or your local Beckman Coulter, Inc. representative for questions or additional information regarding the notification.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

DDR

Quantity affected

20,727

Distribution

Nationwide and Canada.

Date initiated

2007-09-27

Date posted

2009-05-22

Date terminated

2009-05-27

Location

Brea, CA

Related 510(k) clearances