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UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B2446...

FDA Recall #Z-0432-2016 — Class II — December 1, 2015

Recall #Z-0432-2016 Date: December 1, 2015 Classification: Class II Status: Terminated

Product Description

UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.

Reason for Recall

Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager.

Recalling Firm

Beckman Coulter Inc. — Brea, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3,951 units total (1,975 units in US)

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama Philippines, Poland, Portugal, Puerto Rico , Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay, and Vietnam.

Code Information

all serial numbers Part Nos. 629029, B24465, B24802

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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