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U.S. Department of Health and Human Services

Class 2 Device Recall VP 2000 Processor Heated Reagent Basins

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  Class 2 Device Recall VP 2000 Processor Heated Reagent Basins see related information
Date Initiated by Firm July 20, 2010
Date Posted August 31, 2010
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-2313-2010
Recall Event ID 56284
Product Classification Automated Slide Stainer - Product Code KPA
Product 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.
Code Information All basins distributed since September 2008. 
Recalling Firm/
Manufacturer		 Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact
224-361-7133
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Reprocessing Controls
Action 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. ***
Quantity in Commerce 219 basins
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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