Z-1835-2021 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
June 16, 2021
Initiation Date
April 16, 2021
Termination Date
July 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69 units

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.

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.

Code Information

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