Recall Z-2352-2010
Abbott Laboratories · initiated April 16, 2010
Product
CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
Codes / lots: Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- 08H67-01/35286BG-35318BG, 34891BG, 34641BG, 34408BG, 34890BG, 34021BG
Reason for recall
Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
FDA-determined 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.
Details
- Recall number
- Z-2352-2010
- Initiated
- April 16, 2010
- Posted by FDA
- September 2, 2010
- Terminated
- December 6, 2010
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 69 units total
- Distribution
- Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2350-2010 | CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa…Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous… | 04/16/2010Terminated |
| Z-2351-2010 | CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa…Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous… | 04/16/2010Terminated |
| Z-2353-2010 | CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara…Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous… | 04/16/2010Terminated |