QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Reported: July 20, 2016 Initiated: May 24, 2016 #Z-2146-2016
Product Description
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.
Details
- Recalling Firm
- Hardy Diagnostics
- Units Affected
- 25
- Distribution
- U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
- Location
- Santa Maria, CA
Frequently Asked Questions
What product was recalled? ▼
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.. Recalled by Hardy Diagnostics. Units affected: 25.
Why was this product recalled? ▼
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2016. Severity: Moderate. Recall number: Z-2146-2016.
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