Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Drew Excell 22 Hematology Analyzer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Drew Excell 22 Hematology Analyzersee related information
Date Initiated by FirmSeptember 20, 2006
Date PostedJanuary 05, 2007
Recall Status1 Terminated 3 on March 10, 2008
Recall NumberZ-0451-2007
Recall Event ID 36728
510(K)NumberK991539 
Product Classification Hematology Analyzer - Product Code GKZ
ProductDrew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
Code Information All lots.
FEI Number 3003071743
Recalling Firm/
Manufacturer		 Drew Scientific Group PLC
4230 Shilling Way
Dallas TX 75237-1023
Manufacturer Reason
for Recall		System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.
FDA Determined
Cause 2		Other
ActionFirm 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 in Commerce299 units.
DistributionWorldwide 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, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = GKZ
-
-