FDA recall Z-1835-2021

Hardy Diagnostics · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of AK, AR, AZ, CA, GA, KS, MA, MI, MN, MS, NY, OH, PA, RI, SC, TN, TX, WI, WV.

Key facts

Status
Terminated
Initiation date
2021-04-16
Report date
2021-06-16
Termination date
2022-07-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1835-2021