Recall Z-1029-2010 ยท HYB Eosin Y
Wescor, Inc
SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.
| Date | Mar 9, 2010 (initiated Jan 6, 2010) |
| Status | Terminated |
| Reason | Stains used for diagnostic use may be contaminated with bacteria. |
| Root cause | 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 | 116 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 Venezuel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.