FDA Device Intelligence
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Supplement, Culture Media

FDA product code JSK · Class 1 · Microbiology

247
Registered devices
19
Adverse events
6
Recalls
70
510(k) clearances

Devices with this code

UREA 40% — OXOID LIMITEDMod ProCHO 5 powder Sup 2 - 500L — Lonza VerviersCDMN SELECTIVE SUPPLEMENT — OXOID LIMITEDAlpha-Tec Systems — Alpha-TEC Systems, Inc.Alpha-Tec Systems — Alpha-TEC Systems, Inc.TheraPRO® CHO Feed - 1.17 kg — Lonza VerviersCHLORAMPHENICOL SELECTIVE SUPPLEMENT — OXOID LIMITEDSTD L-Glutamine Powder 3kg — Lonza VerviersProCHO5 powder supplement 2 Modified — Lonza VerviersRec. Hum. Insulin ( # 4506) Suppl - 10L — Lonza VerviersAlpha MEM Eagle w/o L-Gln,Sup 1 for 100L — Lonza VerviersDMEM Vitamines Stock 100x 1L — Lonza VerviersAlpha-Tec Systems — Alpha-TEC Systems, Inc.GLS CHO Feed Base S - 50L — Lonza VerviersGLS CHO Feed Base K - 20L — Lonza VerviersSTAPH.-STREP.SELECT.SUPP. — OXOID LIMITEDCAMPYLOBACTER SEL.SUPP.(KARMALI)1X10VIAL — OXOID LIMITEDProduction media supplement 6 - 250 ml — Lonza VerviersN/A — HARDY DIAGNOSTICSAlpha-Tec Systems — Alpha-TEC Systems, Inc.GLS CHO Feed Base M – 20kg — Lonza VerviersAlpha-Tec Systems — Alpha-TEC Systems, Inc.GLS CHO Feed Base U - 5L — Lonza VerviersGLS CHO Feed Base A , 50L License Req. — Lonza Verviers

Recent recalls

DateFirmReason
2015-09-11Acumedia Manufacturers, Inc.Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019.
2015-02-05Remel IncUse of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
2014-11-13Remel IncUse of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
2014-10-17Remel IncRecalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella
2014-01-24Remel IncThe product may contain high levels of microbial contamination
2012-10-10Remel IncThe product may contain low level microbial contamination which could result in incorrect results.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.