Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination of a variety of general chemistries, the

FDA device recall Z-2131-2011 · posted 2011-05-06 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues.

Action taken

The recall communication was initiated on 04/05/2011 with Beckman Coulter forwarding a Product Correction letter with attached customer response form to the affected customers via US Postal Service. The letter informed customers of the products affected, the issue, the impact, and the actions to be taken. Customers were instructed to follow the steps provided in order to address the issues related to microbial contamination; and to complete and return the enclosed response form within 10 days so that receipt of this important information could be confirmed. In addition, the letter requested customers share the information with their laboratory staff and retain the notification as part of your laboratory Quality System documentation. For customers who have any questions regarding this update, the letter indicated to contact Customer Support Center Call Center via the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/. They may also contact Beckman Coulter at (800) 854-3633 in the United States and Canada or through your local Beckman Coulter representative. Beckman Coulter will issue two additional recall notification ("UPDATE TO URGENT PRODUCT CORRECTION Synchron LX20, LX20 PRO, LXi 725 Clinical Systems") beginning on 05/20/2011, one to Laboratory Directors and one to Physicians. The notices will be mailed via US Postal Service on Friday, May 20th. Customers who have subscribed to email notifications will receive an email containing the letters on Monday, May 23th. Both letter informs the Laboratory Directors and Physicians that Beckman Coulter has received reports of erroneous/aberrant sodium, potassium, chloride and calcium results that have been released from the laboratory. Electrolyte shifts can be low or high and may occur above, below or within the normal range. Laboratory Directors were instructed to immediately disseminate the Attachment to this letter (via notification/alert procedure appropriate to your

Root cause

Equipment maintenance

Status

Terminated

Product code

JJE

Quantity affected

1284 units total for all products

Distribution

Worldwide Distribution -- Australia, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Hong Kong, India, Ireland, Italy, Japan, Republic of

Date initiated

2011-04-05

Date posted

2011-05-06

Date terminated

2013-02-06

Location

Brea, CA

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