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U.S. Department of Health and Human Services

Class 2 Device Recall GramPro 1 Automated Gram Stanier

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  Class 2 Device Recall GramPro 1 Automated Gram Stanier see related information
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
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
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
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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