—#98627

Product

CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K972354
Affected lot / code info: List Number 04H60-01; lot number: 61401AF, 61686AF, 61705AF, 62201AF, 62634AF, and 62469AF; Refurbished list number: 04H60-03; lot numbers: 62418AF96, and 60311AF96.

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 #98627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.