The Recall Desk
ModerateFDA (Devices)·Z-1424-2021·Announced 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.

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, but the source text describes a functional defect (lighter growth) that affects measurement accuracy rather than a direct physical or chemical hazard causing injury or illness. No injuries or illnesses are reported, and the risk is limited to potential test inaccuracy, fitting the Moderate category for low-risk functional issues.

Plain-English summary

Remel Inc is recalling 408 units of Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033. The affected lots are 201334 (Exp. 2021-01-21), 210892 (Exp. 2021-02-03), and 217048 (Exp. 2021-02-10). The product was distributed nationwide in the United States.

The recall was initiated because testing with H. influenza ATCC 49247 and ATCC 49766 showed 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 laboratory results.

This product 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 with Haemophilus species. Users should check their inventory for the specific lot numbers listed above and stop using the affected product.

The recalled product

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 wit
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
408

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 (3)

  • Lot Numbers: 201334 Exp. 2021-01-21
  • 210892 Exp. 2021-02-03
  • 217048 Exp. 2021-02-10

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.

See all 2 products in this recall →

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Same hazard · test inaccuracy

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