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

FDA device recall Z-2121-2011 · posted 2011-04-29 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

RETIC results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the RETIC test panel. Beckman Coulter has validated pre-diluted specimen processing in CBC panels. RETIC test panel using pre-diluted samples has not been validated. IMPACT: The reticulocyte value is an indicator for assessing red cell production. Erroneous results could impact c

Action taken

The firm, Beckman Coulter, issued an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation. 2)Do not use pre-diluted samples for RETIC counts. The instrument is validated for pre-diluted CBC's only, as indicated in the Instructions for Use (IFU). 3)Verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and that the Body Fluid results are properly validated at the LIS. 4) Use the lip on the reagent drawer to move the drawer as shown. Avoid touching the drawer slides while replacing containers. Clean all spills promptly to reduce the risk of exposure to blood borne pathogens. 5)Complete and return the enclosed PRODUCT CORRECTIVE RESPONSE FORM within 10 days, share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Beckman Coulter will make corrections in future version software. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.

Root cause

Other

Status

Terminated

Product code

GKZ

Quantity affected

422 units in total (175 in US)

Distribution

Worldwide distribution: USA (nationwide) and countries including:Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Mala

Date initiated

2010-10-20

Date posted

2011-04-29

Date terminated

2014-09-02

Location

Brea, CA

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