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Remel
REMEL, INC. · Model R8311004 · UDI-DI 00848838058110
10
510(k) clearances
32
Adverse events (1 deaths)
9
Recalls
6
Facilities
Description
RapID SS/u System KT/20
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2021-11-09 | Biomerieux Inc | There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test. |
| 2014-05-21 | Becton Dickinson & Co. | A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these |
| 2013-12-11 | AdvanDx, Inc. | Kits incompatible with certain fluorescence microscope light sources |
| 2012-12-13 | Becton Dickinson & Co. | In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification. |
| 2012-09-14 | Advandx Inc | Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-rea |
| 2012-09-14 | Advandx Inc | GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva |
| 2010-10-08 | AdvanDx, Inc. | Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK /P. aeruginosa PNA FISH to produce a false positive red signal |
| 2010-10-06 | AdvanDx, Inc. | Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal. |
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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.