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

FDA device recall Z-2157-2011 · posted 2011-05-09 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

GKZ

Quantity affected

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, M

Date initiated

2011-02-11

Date posted

2011-05-09

Date terminated

2014-09-02

Location

Brea, CA

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