SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. Specifically for use on the Wescor 7120 Hematology Aerospray Slide Stainer and is intended for use by medical professionals to stain specimens that may include blood and other body fluids as a step of standard laboratory practice in diagnosing disease in humans.
FDA Recall Z-1027-2010 · Posted 2010-03-09
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Recalling FirmWescor, Inc
Recall StatusTerminated
Product CodeHYB
Date Initiated2010-01-06
Date Terminated2010-04-20
Product Quantity24,466 bottles
Reason for Recall
Stains used for diagnostic use may be contaminated with bacteria.
Firm Action
Customers were notified by letter on Jan. 6, 2010 and asked to destroy any remaining product. A response form was included to note whether or not customer had any remaining stock for replacement purposes. Additional information is available at 800-453-2725 or [email protected].
Root Cause
Component design/selection
Distribution Pattern
Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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