Z-1835-2021 Class II Terminated
FDA device recall Z-1835-2021 was initiated by Hardy Diagnostics on April 16, 2021 and is designated Class II. Reason for recall: Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. The recall status is terminated (terminated July 28, 2022). Affected quantity: 69 units.
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