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Terminated

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

FDA Recall Z-1835-2021 · Posted None

Recalling FirmHardy Diagnostics
Recall StatusTerminated
Product CodeKPA
Date Initiated2021-04-16
Date Terminated2022-07-28
Product Quantity69 units

Reason for Recall

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

Firm Action

On 05/06/2021, Hardy Diagnostics issued an Urgent Medical Device Removal notice to customers via letter notifying them the GramPro 1 Automated Slide Stainer may have defective tubing, part of the pump mechanism within the unit.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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