FDA Medical Device Recalls (openFDA)
Wescor, Inc: SS-035CG, Hematology Reagent C Eosin Stain, 1 U.S. Gallon, 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.
- Recall number
- Z-1028-2010
- Recalling firm
- Wescor, Inc
- Product
- SS-035CG, Hematology Reagent C Eosin Stain, 1 U.S. Gallon, 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.
- Status
- Terminated
- Initiated
- 2010-01-06
- Posted
- 2010-03-09
- Terminated
- 2010-04-20
- 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
- 2380 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.
- Lot, serial or model codes
- Lot numbers: 102560, 102996, 103493, 103840, 104594 and 105052.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HYB
- Firm FEI
- 1717966
- Firm city
- Logan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28