Hardy Diagnostics Recall 87850
Description: Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Hardy Diagnostics Recall 87850 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1835-2021 |
| Event ID | 87850 |
| Event Description | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. |
| Product Type | Devices |
| 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. |
| Quantity | 69 units |
| Recall Reason | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. |
| Device Classification | 20210616 |
| Device 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 |
| Center Classification Date | 20210609 |
| Recall Initiation Date | 20210416 |
| Recalling Firm | Hardy Diagnostics |
| Initial Notification | Letter |
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