VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: a) list 02J11-013, part number 30-144152 (replacement basins); b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory.
Recall
- Recall Number
- Z-2313-2010
- Event Number
- 56284
- Firm
- Abbott Molecular
- FEI Number
- 3005248192
- Product Code
- KPA
- Status
- Terminated
- Root Cause
- Reprocessing Controls
- Initiated
- July 20, 2010
- Posted
- August 31, 2010
- Terminated
- April 19, 2012
- Address
- 1300 E Touhy Ave, Des Plaines, IL, 60018-3315
Description
VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: a) list 02J11-013, part number 30-144152 (replacement basins); b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory.
The VP2000 Processor Heated Reagent Basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.
Abbott sent Urgent Product Recall letters dated 7/20/10 to the VP 2000 Processor customers on same date via FedEx, informing them that the heated reagent basins could crack along the bottom seam, have non-uniform coating of interior corners, warping of the aluminum housing or incorrect dimensions. These deficiencies could result in leakage or the inability to place the basins into the VP 2000 Processor, resulting in possible exposure to chemical reagents, a slippery floor hazard, and/or delay or failure to start a protocol run. An Abbott Molecular customer service representative will call them to coordinate replacement of all of their heated reagent basins before 10/31/10. Customers were to complete and return the Customer Reply form provided. Any questions were directed to their local Abbott Molecular Representative. *** A second recall letter was sent to all customers on 12/21/10 explaining that the VP 2000 heated reagent basins previously inspected and determined to be acceptable could develop a leak, and that they would be contacted by an Abbott Molecular Customer Service Representative or Field Service representative in early 2011 to coordinate replacement of all of their VP 2000 heated reagent basins. ***
Worldwide Distribution -- Australia, Belgium, France, Germany, India, Italy, Japan, Pakistan, Poland, Russia, Singapore, South Korea, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, and the United States.
219 basins