FDA Device recall Z-2146-2016
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80 by Hardy Diagnostics, citing discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2146-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-24 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hardy Diagnostics |
| Distribution | AZ, CA, LA, MI, NC, NE, NM, NY, OK, PA, TX, VA, WV |
Product
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Reason
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Identifiers
| code_info | All units manufactured between October 2014 and May 2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2146-2016%22
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