Dako CoverStainer Microscope Slide Stainer Recalled for Plexiglass Door Breakage
Agilent Technologies recalls Dako CoverStainer microscope slide stainers due to potential plexiglass door breakage that could cause injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm product (plexiglass door breakage that could cause injury) with no reported injuries or hospitalizations. Per the severity rubric, this meets the criteria for a 'High' (score 3) classification as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Agilent Technologies is recalling the Dako CoverStainer and Dako CoverStainer CPO microscope slide stainers. These devices are in vitro diagnostic instruments used in laboratory and pathology settings to automatically stain microscope slides for diagnostic testing. The affected models include CS10030, CS10040, CS10026, and CS10026E.
The front plexiglass door of the automated slide processing system has the potential to break, which could cause injury to users.
Approximately 1,160 devices have been distributed worldwide, including throughout the United States and numerous countries internationally. In the U.S., the recall includes devices in California, Tennessee, Michigan, Maryland, Massachusetts, Oregon, Alaska, Missouri, North Carolina, New Hampshire, Georgia, and Rhode Island. All lot codes are included in the recall.
The recalled product
- Product
- Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
- Manufacturer
- Agilent Technologies
- Hazard
- Affected units
- 1,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: All Lots
Distribution
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