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U.S. Department of Health and Human Services

Class 3 Device Recall Eosin stain

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  Class 3 Device Recall Eosin stain see related information
Date Initiated by Firm January 06, 2010
Date Posted March 09, 2010
Recall Status1 Terminated 3 on April 20, 2010
Recall Number Z-1027-2010
Recall Event ID 54187
Product Classification Eosin Y - Product Code HYB
Product 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.
Code Information Lot numbers: 102336, 102783, 103108, 103492, 103839, 104398, 104844 and 105163.
Recalling Firm/
Manufacturer		 Wescor, Inc
1700 S 370 W
Logan UT 84321
For Additional Information Contact
435-752-6011
Manufacturer Reason
for Recall		 Stains used for diagnostic use may be contaminated with bacteria.
FDA Determined
Cause 2		 Component design/selection
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 regaff@wescor.com.
Quantity in Commerce 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, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.
Total Product Life Cycle TPLC 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.
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