Recall Z-2313-2010 ยท KPA Slide Stainer, Automated
Abbott Molecular
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
| Date | Aug 31, 2010 (initiated Jul 20, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 th |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.