Q-Slide™

HARDY DIAGNOSTICS · Model Z302 · UDI-DI 00819398028707

510(k) clearances

Adverse events

Recalls

Facilities

Description

Q-Slide™ Gram, a prepared control slide for the QC of the gram stain, has E. coli and S. aureus, pre-inoculated, 5 slides per box A convenient ready-to-stain control slide that will test both your stain solutions and your staining techniques. Positive and negative stain control organisms are affixed to the circles in each Q-Slide™. Up to four patient specimens (in the squares) may be processed at the same time as the QC organisms.

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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Data 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.