Recalls / —

—#53403

Product

Abbott CELL-DYN 3500 Hematology Analyzer

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K913305, K955715, K960427, K980614, K991605

Affected lot / code info

Model number CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03, all serial numbers distributed before May 3, 2007. Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03, all serial numbers distributed on or before May 3, 2007: 91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P, 91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96, 91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000, 91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000

Why it was recalled

The product failed electrostatic discharge testing, which could result in product failure.

Root cause (FDA determination)

Other

Action the firm took

Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.

Recalling firm

Firm

Abbott Laboratories

Address

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

Distribution

Distribution pattern

Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.

Timeline

Recall initiated

2007-05-11

Posted by FDA

2007-08-29

Terminated

2008-06-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #53403. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.