—#93219

Product

CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K051215
Affected lot / code info: Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- 08H00-01/42297AZ, 42909AZ, 42080AZ, 42410AZ

Why it was recalled

Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.

Timeline

Recall initiated: 2010-04-16
Posted by FDA: 2010-09-02
Terminated: 2010-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.