FDA Recall Terminated

CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.

Recall: Z-1069-2010 · Initiated August 17, 2009

Recall

Recall Number
Z-1069-2010
Event Number
54076
Firm
Becton Dickinson & Co.
FEI Number
1119779
Product Code
JQC
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
August 17, 2009
Posted
March 11, 2010
Terminated
April 22, 2010
Address
7 Loveton Cir, Sparks, MD, 21152-9212

Description

CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.

Reason

Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.

Action

An "Urgent Product Recall" letter dated August 2009 was sent to the customers. The letter described the affected product, problem and the action to be taken by customers. The customers were advised to discontinue use of the centrifuge for repair or replacement with refurbished unit , provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so that BD may inform them of the issue,and return the enclosed response form. For further assistance regarding product replacement and returns contact our Technical Services Department at 1-800-638-8663.

Distribution

Worldwide distribution: USA and Mexico, Phillipines, Columbia, Chile, Ecuador, Venezuela, Puerto Rico, Canada and Singapore.

Quantity

411 units