Recall
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by…
Beckman Coulter Inc. · 20 June 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.”
- Recall began
- 20 June 2017
- Company
- Beckman Coulter Inc.
- Device type
- Product code (GKZ)
- Concerns
- K140911
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.