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QSlide™
HARDY DIAGNOSTICS · Model QS0700 · UDI-DI 00819398026987
10
510(k) clearances
0
Adverse events
5
Recalls
17
Facilities
Description
A prepared slide containing dried and methanol fixed samples of S.aureus and E.coli for the quality control of Gram stain reagents on the Quickslide automated Gram stainers, and also for manual staining. 50 slides per case
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-18 | Opgen Inc | May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test |
| 2018-05-14 | Opgen Inc | Possible diminished performance prior to its established expiration date. |
| 2013-02-11 | Microbiologics Inc | 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 becaus |
| 2012-05-29 | Microbiologics Inc | 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 cau |
| 2003-11-03 | Remel, Inc. | Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.