Z-2146-2016Class II

QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes...

Name: Z-2146-2016 QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes...
Creator: Hardy Diagnostics
Published: 2016-05-24
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2016-05-24 / Terminated

FDA source

Hardy Diagnostics began a recall of QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample... on 2016-05-24. FDA classified it as Class II and gives the reason as "Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2146-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-24
Posted: 2016-07-08
Terminated: 2017-03-03
Recalling firm: Hardy Diagnostics
Product: QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Product code: KPA Slide Stainer, Automated
Reason for recall: Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
FDA root cause: Under Investigation by firm
Action: The 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 [email protected].
Quantity in commerce: 25
Distribution: U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
Product codes and lots: All units manufactured between October 2014 and May 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2146-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2146-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-08

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)