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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (lighter growth) that may affect test measurement accuracy without reports of direct patient injury or death.
Plain-English summary
Remel Inc is recalling 19 units of Remel Haemophilus Test Medium (100mm) 10/PK, Reference R01503. The affected lot is 220711 with an expiration date of 2021-2-17. The product was distributed nationwide in the United States.
The recall was initiated because testing with H. influenza ATCC 49247 and ATCC 49766 revealed that both organisms may exhibit lighter than normal growth. This issue can make antimicrobial disk diffusion test zones difficult to measure, potentially affecting the accuracy of qualitative procedures recommended by the Clinical and Laboratory Standards Institute (CLSI).
This recall involves a Class II medical device. Users of the affected product should stop using the recalled units and contact Remel Inc for further instructions or a replacement.
The recalled product
- 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 wi
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: Lot 220711 Exp. 2021-2-17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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