—#98895

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: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081930
Affected lot / code info: All serial numbers, SW version 1.1.3.0

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated: 2010-10-20
Posted by FDA: 2011-04-29
Terminated: 2014-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98895. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.