SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. Specifically for use on the Wesc
FDA device recall Z-1027-2010 · posted 2010-03-09 · Terminated
Recall details
- Recalling firm
- Wescor, Inc
- Reason for recall
- Stains used for diagnostic use may be contaminated with bacteria.
- Action taken
- 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 regaff@wescor.com.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HYB
- Quantity affected
- 24,466 bottles
- Distribution
- Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saud
- Date initiated
- 2010-01-06
- Date posted
- 2010-03-09
- Date terminated
- 2010-04-20
- Location
- Logan, UT
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