The Recall Desk

FDA (Devices) recall action 87495

Remel Inc recalled 2 products on 2021-04-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-04-21
Critical
0
Units
427

Why these products were recalled

When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2021-04-21

    Remel Haemophilus Test Medium Recalled Due to Growth Issues

    Remel Inc is recalling 408 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-04-21

    Remel Haemophilus Test Medium Recalled for Reduced Organism Growth

    Remel Inc is recalling 19 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests…
    Category
    Distribution
    0 states