Recall Z-1835-2021 ยท KPA Slide Stainer, Automated
Hardy Diagnostics
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
| Date | Apr 16, 2021 |
| Status | Terminated |
| Reason | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 69 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.