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HARDY DIAGNOSTICS · Model J44 · UDI-DI 00816576020195
JTY
Prescription
10
510(k) clearances
82
Adverse events
9
Recalls
6
Facilities
Description
CHOC. / M.L. with LINCO. BIPLATE (Chocolate Agar / Martin Lewis with Lincomycin). A biplate for the cultivation and isolation of Neisseria gonorrhoeae.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-03 | Remel, Inc | Reduced or no recovery of some strains of Neisseria gonorrhoeae. |
| 2022-11-21 | Becton Dickinson & Co. | Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction c |
| 2021-03-17 | Becton Dickinson & Co. | Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the |
| 2021-03-17 | Becton Dickinson & Co. | Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the |
| 2018-06-21 | Becton Dickinson & Co. | A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium t |
| 2013-02-08 | Becton Dickinson & Co. | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. |
| 2003-10-10 | Becton Dickinson & Co | Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species. |
| 2003-10-02 | Remel, Inc | Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae |
| 2002-11-18 | Becton Dickinson & Co. | Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species. |
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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.