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Terminated

Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

FDA Recall Z-0450-2007 · Posted 2007-01-05

Recalling FirmDrew Scientific Group PLC
Recall StatusTerminated
Product CodeGKZ
Date Initiated2006-09-20
Date Terminated2008-03-10
Product Quantity545 units.

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991539EXCELL 22Mwi, Inc. · 1999-07-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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