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U.S. Department of Health and Human Services

Class 2 Device Recall QuickSlide MGS80 MutliSlide Gram Stainer/GramPRO80

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 Class 2 Device Recall QuickSlide MGS80 MutliSlide Gram Stainer/GramPRO80see related information
Date Initiated by FirmMay 24, 2016
Date PostedJuly 08, 2016
Recall Status1 Terminated 3 on March 03, 2017
Recall NumberZ-2146-2016
Recall Event ID 74356
Product Classification Slide stainer, automated - Product Code KPA
ProductQuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Code Information All units manufactured between October 2014 and May 2016.
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information ContactDaniel Crawford
940-692-3135 Ext. 7
Manufacturer Reason
for Recall		Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm began notifying consignees via phone on 05/23/16. The firm also sent out Urgent Notification letters, dated June 15, 2016. The firm's phone script instructs customers to decrease the number of rinses on the slide and increasing the number of rinses in the chamber for better outcomes and performance with the instrument. Reducing the rinses on the slide may prevent bacteria from coming off the slide, and adding rinses to the empty chamber will help ensure that the chamber is clean before the next slide is introduced. The firm's customer notification letter recommended an immediate update to the automated rinse cycle to decrease the number of slide rinses and increase the number of empty chamber rinses to improve instrument performance. A step-by-step procedure for updating the rinse cycle settings was discussed via phone and should now be implemented. In addition to the changes, the firm is updating the GramPro 80 User Manual to reflect new recommendations, and it is strongly recommended that all users perform methanol fixation of slides for automated staining and discontinue the use of heat fixation to prevent cross contamination of the unit. Once updates to the User Manual have been completed, the firm will provide an updated revision for customer records. For further information or technical assistance, contact QuickSlide Technical Team at gibbsd@HardyDiagnostics.com.
Quantity in Commerce25
DistributionU.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
Total Product Life CycleTPLC 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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