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

FDA device recall Z-1977-2011 · posted 2011-04-13 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous results. IMPACT: Erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu

Action taken

The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with PCA Response Form (via US Postal Service for US customers) dated October 20, 2010, to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter describes the product, problem and the following actions to be taken. The customers were instructed to remove all cassettes from the mix station prior to initiating the Diluent Dispense function to prevent the likelihood of a specimen being diluted; do not use pre-diluted samples for RETIC counts; 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 the Body Fluid results are properly validated at the LIS. This will be corrected in a future version; use the lip on the reagent drawer as shown in the picture above; avoid touching the drawer slides while replacing containers; clean all spills promptly to reduce the risk of exposure to blood borne pathogens; complete and return enclosed PRODUCT CORRECTIVE ACTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7503/7504; mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015 or email to: Regulatory.Notifications@beckmancoulter.com, and share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If you have any questions regarding this PCA, contact 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, Mal

Date initiated

2010-10-20

Date posted

2011-04-13

Date terminated

2014-09-02

Location

Brea, CA

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