Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Reports per year

Source: FDA adverse event reports by year received, 1994–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-11-21Open, ClassifiedUnder Investigation by firm

  1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

  Products may contain contamination, which may result in a darker or brown media color.

• 2011-06-21TerminatedNonconforming Material/Component

  BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.

  Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.

• 2010-01-15TerminatedNonconforming Material/Component

  remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).

  The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.

• 2009-09-30TerminatedEmployee error

  Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.

  Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.

• 2009-01-28TerminatedNonconforming Material/Component

  HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box

  Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.

• 2005-08-31TerminatedOther

  Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.

  Microbiological media for antibiotic susceptibility testing gives false test results.

• TerminatedUnder Investigation by firm

  CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.

  Product may have incorrect cation information detailed on the product label.

• TerminatedUnder Investigation by firm

  remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

  Product may fail performance testing for S aureus ATCC 43300.