Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro diagnostic u

FDA device recall Z-2227-2011 · posted 2011-05-20 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.

Action taken

The recall communication was initiated on 4/12/11 with Beckman Coulter forwarding an Urgent Product Correction (PC) letter with attached PC Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH" 800 Coulter Cellular Analysis System PN 629029. The letter provides customers with an explanation of the problem identified and an action to be taken. For Issue 1 & 2, customers were instructed to perform manual database maintenance procedures to locate and delete unnecessary patient result and demographic information that extends beyond the life (in days) of the control lots. Ensure an alternative method of analysis is available during database maintenance. For Issue 3, customers were instructed to not attempt to transmit the files again after receiving an incomplete report. Instead, submit the missing file(s) by one of the following methods: - Submit your data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) - Fax printouts of the missing files to 786-639-3999 - Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com. - Include the IQAP number on any communication. A corrected report will be returned to the customers' laboratories. For issue 4, customers were instructed to submit their control data to IQAP by one of the following methods: -Submit their data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) -Fax printouts of the missing files to 786-639-3999 -Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com. -Include your IQAP number on any communication. Customers were instructed to complete and return the enclosed Response Form within ten days. Customers were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Root cause

Software design

Status

Terminated

Product code

GKZ

Quantity affected

673 units

Distribution

Worldwide Distribution -- US, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Macao, Malaysi

Date initiated

2011-04-14

Date posted

2011-05-20

Date terminated

2012-05-23

Location

Brea, CA

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