Beckman Coulter Inc.: Synchron LX 20 The Synchron LX Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF); (sample type is chemistry dependent). Additionally, Synchron LX PRO Systems include Closed Tube Sampling (CTS) and Large Particle Immuno Assay (LPIA).

Recall number

Z-2072-2011

Recalling firm

Beckman Coulter Inc.

Product

Synchron LX 20 The Synchron LX Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF); (sample type is chemistry dependent). Additionally, Synchron LX PRO Systems include Closed Tube Sampling (CTS) and Large Particle Immuno Assay (LPIA).

Status

Terminated

Initiated

2010-10-22

Posted

2011-04-26

Terminated

2014-09-02

Reason

This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified.

Root cause

Environmental control

Action

The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.

Quantity

1410 units total (503 in US)

Distribution

Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.

Lot, serial or model codes

Part Number: 466200  Subsequent Product Codes: CDS, CEK, CEM, CEO, CGA, CGX, CGZ, CIX, JFL, JFP, JGS, JIX

510(k) numbers

["K011213"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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