Recall Z-0448-2007 ยท GKZ Counter, Differential Cell
Drew Scientific Group PLC
Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
| Date | Jan 9, 2007 (initiated Aug 24, 2006) |
| Status | Terminated |
| Reason | Flags and alerts on the user interface will not automatically transfering to the LIS. |
| Root cause | Other |
| Action | Firm sent 'Product Notification #22' to all customers on 08/24/06. Users advised of potential risk to patient health and provided with instructions on how to eliminate risk by disabling the auto transfer feature and manually transfering data until a software patch is made available |
| Quantity | 545 units. |
| Distribution | Worldwide distribution --- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991539 | EXCELL 22 Mwi, Inc., Jul 1, 1999 |