Recalls / —

—#98628

Product

CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics Division, Santa Clara, CA 05054

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K061667

Affected lot / code info

List Number 08H67-01; lot numbers: 35678BG, 35682BG to 35759BG, 35761BG to 35768BG, 35771BG, 34163BG, 34283BG, 34090BG, and 34862BG.

Why it was recalled

The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.

Root cause (FDA determination)

Pending

Action the firm took

Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.

Recalling firm

Firm

Abbott Laboratories

Address

5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern

Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.

Timeline

Recall initiated

2011-03-15

Posted by FDA

2011-04-29

Terminated

2011-11-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #98628. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.