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Acid Fast Control Slide (pack of 50 slides)
ELITECHGROUP INC. · Model SS-249 · UDI-DI 03661540303982
10
510(k) clearances
0
Adverse events
5
Recalls
17
Facilities
Description
Colored slides to be used with Aerospray® TB slide stainer/cytocentrifuges to aid in identifying cells.
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.