| Class 2 Device Recall GramPro 1 Automated Gram Stanier |  |
Date Initiated by Firm | April 16, 2021 |
Create Date | June 09, 2021 |
Recall Status1 |
Terminated 3 on July 28, 2022 |
Recall Number | Z-1835-2021 |
Recall Event ID |
87850 |
Product Classification |
Slide stainer, automated - Product Code KPA
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Product | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. |
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 |
Recalling Firm/ Manufacturer |
Hardy Diagnostics 1430 W McCoy Ln Santa Maria CA 93455-1005
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For Additional Information Contact | Sue Pruett 805-346-2766 |
Manufacturer Reason for Recall | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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