FDA Medical Device Recalls (openFDA)
Hardy Diagnostics: QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
- Recall number
- Z-2146-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-05-24
- Posted
- 2016-07-08
- Terminated
- 2017-03-03
- Reason
- Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
- 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 gibbsd@HardyDiagnostics.com.
- Quantity
- 25
- Distribution
- U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
- Lot, serial or model codes
- All units manufactured between October 2014 and May 2016.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPA
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28