QuickSlide MGS-80 — Class II medical device recall Z-2146-2016
Terminated recall by Hardy Diagnostics, reported 2016-07-20, distributed in AZ, CA, LA, MI, NC, NE, NM, NY…. Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment
| Recall number | Z-2146-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2016-05-24 |
| Classified | 2016-07-08 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-03-03 |
| Distributed | AZ, CA, LA, MI, NC, NE, NM, NY, OK, PA, TX, VA, WV |
| Quantity | 25 |
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 for recall
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2146-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.