Quality Control Slides
Microbiology · 21 CFR 866.2660
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
5 recall events for this product code
- Microbiologics IncTerminatedMar 28, 2013
Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides).
Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could pote
Z-1021-2013 · View FDA record ↗ - Microbiologics IncTerminatedJul 3, 2012
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B
Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and improper treatment of a patient.
Z-1936-2012 · View FDA record ↗ - Remel, Inc.TerminatedDec 25, 2003
Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area
Z-0273-04 · View FDA record ↗ - Opgen IncTerminatedUnknown
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Z-1328-2019 · View FDA record ↗ - Opgen IncTerminatedUnknown
AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012
Possible diminished performance prior to its established expiration date.
Z-2439-2018 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
Fertility Solutions, Inc.
Warrensville Heights, OH, US
Elitechgroup Inc
LOGAN, UT, US
Scytek Laboratories, Inc.
LOGAN, UT, US
Calibrescientific Us, Inc.
VANCOUVER, WA, US
Remel, Inc.
LENEXA, KS, US
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
Slee Medical Gmbh
Nieder-Olm Rhineland-Palatinate, DE
Springside Scientific Llc
Durham, NC, US
Becton, Dickinson & Co.
SPARKS, MD, US
Hardy Diagnostics
Orcutt, CA, US
Mercedes Medical Llc
Lakewood Ranch, FL, US
Phadia Us Inc.
Portage, MI, US
Newcomer Supply Inc
Waunakee, WI, US
Hardy Diagnostics
Springboro, OH, US
Microbiologics, Inc.
Saint Cloud, MN, US
Bion Enterprises, Ltd.
DES PLAINES, IL, US
Bio Sb, Inc.
Santa Barbara, CA, US
510(k) clearances
27 clearances for this product code
- Meridian Diagnostics, Inc.Oct 27, 1994
K943228 · MICROSPORIDIUM CONTROL SET
- Scientific Device Laboratory, Inc.Jan 15, 1993
K924893 · MICROSPORIDIUM CONTROL SLIDE
- Scientific Device Laboratory, Inc.Mar 16, 1989
K890718 · GRAM STAIN CONTROL SLIDE
- Scientific Device Laboratory, Inc.Mar 16, 1989
K890670 · CRYPTOSPORIDIUM CONTROL SLIDE
- Bion Ent., Ltd.Feb 17, 1989
K890616 · BION DIRECT IDENTIFICATION CONTROL SLIDE
- Val Tech Diagnostics, Inc.Oct 6, 1988
K883570 · HISTO-CHECK FUNGAL CONTROL SLIDES
- Val Tech Diagnostics, Inc.Oct 6, 1988
K883567 · HISTO-CHECK LEGIONELLA CONTROL SLIDES
- Val Tech Diagnostics, Inc.Oct 6, 1988
K883569 · HISTO-CHECK GRAM NEGATIVE SLIDES