CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
- Company
- Abbott Laboratories
- Recall Initiated
- April 16, 2010
- Posted
- September 2, 2010
- Terminated
- December 6, 2010
- Recall Number
- Z-2350-2010
- Quantity
- 69 units total.
- Firm Location
- Santa Clara, CA
Reason for Recall
Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
Distribution
Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.
Lot / Code Info
Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- CS: 04H59-01/30664AH, 4H59-03/30276AH96, 30671AH96, 30673AH96. SL: 04H60-01, 62794AF-62799AF, 62144AF, 62772AF, 62073AF, 61628AF, 61376AF
Root Cause
Nonconforming Material/Component
Action Taken
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.