Z-1027-2010

SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. Specifically for use...

Name: Z-1027-2010 SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. Specifically for use...
Creator: Wescor, Inc
Published: 2010-01-06
License: https://open.fda.gov/license/

ELITechGroup Inc / initiated 2010-01-06 / Terminated / root cause: design

FDA source

Wescor, Inc began a recall of 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... on 2010-01-06. The reason FDA records is "Stains used for diagnostic use may be contaminated with bacteria". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1027-2010
Status: Terminated
Initiated: 2010-01-06
Posted: 2010-03-09
Terminated: 2010-04-20
Recalling firm: ELITechGroup Inc
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.
Product code: HYB Eosin Y
Reason for recall: Stains used for diagnostic use may be contaminated with bacteria.
Root cause tag: design
FDA 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 [email protected].
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.
Product codes and lots: Lot numbers: 102336, 102783, 103108, 103492, 103839, 104398, 104844 and 105163.

Product code HYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)