Recall Z-1835-2021— Hardy Diagnostics

Name: FDA recall Z-1835-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-16

Class II · Terminated

Class II FDA medical device recall by Hardy Diagnostics, initiated 2021-04-16, terminated 2022-07-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.. Reason: Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit..

Recalling firm: Hardy Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Terminated: 2022-07-28
Firm location: Santa Maria, CA, United States

Product description

Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.

Reason for recall

Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

Data sourced from openFDA. This site is unofficial and independent of the FDA.