Beckman Coulter Inc.: UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

Recall number

Z-2157-2011

Recalling firm

Beckman Coulter Inc.

Product

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

Status

Terminated

Initiated

2011-02-11

Posted

2011-05-09

Terminated

2014-09-02

Reason

The recall was initiated because: The handheld barcode scanner does not read barcode labels using NW 7 symbology. Impact: Specimens with NW7 labels cannot be read by the handheld scanner.

Root cause

Pending

Action

Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Consignees were informed of the reasons for recall, products affected and resolution for these issues would be corrected in a future release(s) for the DxH 800; but were also asked to take the following actions: If they use NW7 bar code symbiology, the labels can be read using one of the following methods: - At the single-tube presentation station (using the internal bar code scanner) - Enter the bar code information manually at the user interface of the single-tube station - Use cassette presentation. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, consignees were told to contact Beckman Coulter Customer Service at 800526- 7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Quantity

566 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia ,Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, and the United Kingdom

Lot, serial or model codes

All Serial Numbers are affected.

510(k) numbers

["K081930"]

PMA numbers

not on file

Product code

GKZ

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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