UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, mult

FDA device recall Z-0147-2014 · posted 2013-11-04 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb

Action taken

The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated September 12, 2013, its customers. The letter includes the products descriptions and codes, issue, impact, action, resolution, instructions to the customers, and contact information. The customers were instructed to review the three samples analyzed prior to error message,if you experience a "Vent/overflow chamber detected overflow' error; to avoid physical contact with a possible leak by continuing to use personal protective equipment as recommended in the Instructions for Use and by national regulations; share this information with your staff and retain this notification as part of your Quality System documentation; if you have forwarded any of the affected products, provide them a copy of this letter; and to complete and return the enclosed RESPONSE FORM within 10 days via fax to: 786-639-7500 /7501/7502/7504; email: Regulatory.Notifications@beckmancoulter.com (note: please include "DxH system check valve letter dated 09/12/2013" in email subject field) and/or by mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami Fl 36116-9015. . Your service representative will contact you to schedule an on-site visit for check valve inspection and replacement of any affected valves. If you have any questions concerning this notification, please contact our Customer Support Center: via our website, http://www.beckmancoulter.com/customersupport/support, via phone, call 800-526-7694 in the United States and Canada, and Outside US and Canada, contact your local Beckman Coulter Representaitive.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GKZ

Quantity affected

1,025 units

Distribution

Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, M

Date initiated

2013-09-24

Date posted

2013-11-04

Date terminated

2014-04-21

Location

Brea, CA

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