Z-2157-2011

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a...

Name: Z-2157-2011 UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a...
Creator: Beckman Coulter Inc.
Published: 2011-02-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-02-11 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro... on 2011-02-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2157-2011
Status: Terminated
Initiated: 2011-02-11
Posted: 2011-05-09
Terminated: 2014-09-02
Recalling firm: Siemens Healthcare Diagnostics 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).
Product code: GKZ Counter, Differential Cell
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: All Serial Numbers are affected.

Product code GKZ

K081930Class IIUnicel Dxh 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. / cleared 2008-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)