Recalls / —

—#25034

Product

Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K010953, K961439, K971152, K981342

Affected lot / code info

Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003)

Why it was recalled

Product elicits fluorescent signal interference due to contamination.

Root cause (FDA determination)

Other

Action the firm took

On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

Recalling firm

Firm

Abbott Laboratories

Address

5440 Patrick Henry Drive, Santa Clara, California 95054

Distribution

Distribution pattern

Nationwide and Argentina, Canada and Puerto Rico.

Timeline

Recall initiated

2002-10-16

Posted by FDA

2003-03-13

Terminated

2003-08-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.