Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
- Company
- Hardy Diagnostics
- Recall Initiated
- April 16, 2021
- Terminated
- July 28, 2022
- Recall Number
- Z-1835-2021
- Quantity
- 69 units
- Firm Location
- Santa Maria, CA
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.
Lot / Code Info
Lot Numbers: 1654, 1657, 1658, 1660, 1661, 1662, 1663. Serial Numbers: 354, 417, 422, 462, 472, 473, 480, 488, 490, 491, 496, 503, 505, 513, 521, 522, 526, 536, 551, 562, 564, 589, 590, 592, 596, 603, 606, 616, 620, 621, 622, 623, 624, 625, 626, 627, 628, 629, 630, 631, 632, 633, 634, 635, 636, 637, 638, 639, 640, 641, 642, 643, 644, 645, 646, 647, 648, 649, 650, 651, 652, 653, 654, 655, 656, 657, 658, 2005,2012
Root Cause
Nonconforming Material/Component
Action Taken
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.