The Recall Desk
ModerateFDA (Devices)·Z-1400-2017·Announced 2017-03-15

Remel Haemophilus Test Medium Recalled for Poor Organism Growth

Remel Inc is recalling Haemophilus Test Medium agar plates because poor organism growth may result in incorrect susceptibility test results.

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: This is a voluntary precautionary recall for a quality defect (poor growth) that affects test accuracy but does not present a direct physical safety hazard like injury or infection.

Plain-English summary

Remel Inc is voluntarily recalling specific lots of Haemophilus Test Medium (Agar) in 100 mm and 150 mm plates. The recall affects Lot 978596 (100 mm) and Lot 978948 (150 mm), both with a use-by date of January 30, 2017.

The recall was initiated because test organisms exhibit poor growth when using the affected agar. This poor growth can lead to incorrect antibiotic susceptibility test (AST) zones, potentially compromising the accuracy of laboratory results.

The affected products were distributed nationwide in the United States, including Puerto Rico and all 50 states. Users should stop using the recalled lots and contact Remel Inc for further instructions or a replacement.

The recalled product

Product
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Reagents
Hazard

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 (4)

  • A) Lot: 978596
  • 2017-01-30
  • B) Lot: 978948
  • 2017/01/30

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Related recalls

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Same hazard · inaccurate test results

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