Recall Z-0451-2007 ยท GKZ Counter, Differential Cell
Drew Scientific Group PLC
Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
| Date | Jan 5, 2007 (initiated Sep 20, 2006) |
| Status | Terminated |
| Reason | System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts. |
| Root cause | Other |
| Action | Firm sent 'Technical Bulletin #39' to all customers on 09/20/06. Users advised of potential for inaccurate readings and provided with instructions on how to eliminate problem. |
| Quantity | 299 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 |