Becton Dickinson Recalls Martin-Lewis Agar Due to Fungal Growth
Becton Dickinson is recalling Martin-Lewis Agar plates because they show heavy fungal growth, which may delay the diagnosis of Neisseria infections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of delayed diagnosis and treatment for pathogenic infections, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling 33,660 units of BD BBL Martin-Lewis Agar (Catalog Number 221557, Lot Number 0317558). The product is a laboratory medium used to isolate pathogenic Neisseria from specimens containing mixed bacteria and fungi.
The recall is due to a misformulation that causes heavy growth of C. albicans after 24 hours of incubation. The expected reaction is partial inhibition of fungal growth after 18 to 48 hours. This excessive fungal growth can reduce the ability to identify Neisseria, potentially contributing to a delay in definitive diagnosis or proper treatment.
The affected products were distributed worldwide, including the United States, Canada, and Korea. Users should stop using the affected lot and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 33,660
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 (2)
- Lot Number: 0317558
- Exp. Date 2021-MAR-11 UDI: (01)30382902215579 (10)0317558(17)031121 (30)0020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Co. 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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