FDA Medical Device Recalls (openFDA)
Drew Scientific Group PLC: Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
- Recall number
- Z-0451-2007
- Recalling firm
- Drew Scientific Group PLC
- Product
- Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
- Status
- Terminated
- Initiated
- 2006-09-20
- Posted
- 2007-01-05
- Terminated
- 2008-03-10
- 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, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K991539"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 3003071743
- Firm city
- Dallas
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28