Recalls / —

—#98629

Product

CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K991605

Affected lot / code info

List Number 8921204902:  Date Code 20-Jan-2011 Pallet ID 48312339; Date Code 08-Feb-2011 Pallett ID 95795162.  List Number 8921167602: Date Code 13-Dec-2010 Pallet ID 80671954; Date Code 15-Dec-2010 Pallet ID 32777397; Date Code 16-Dec-2010 Pallet ID 46425128; Date Code 18-Jan-2011 Pallet ID 42387574; and Date Code 20-Jan-2011 Pallet ID 35758457.

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 #98629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.