BD BBL Martin-Lewis Agar Recalled for Misformulation and Fungal Growth
Becton Dickinson is recalling BD BBL Martin-Lewis Agar due to misformulation causing 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. The hazard involves a delay in diagnosis and treatment of Neisseria infections, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling 15,550 units of BD BBL Martin-Lewis Agar (Catalog Number 221558). The affected lots are 0317559 (Exp. Date 2021-MAR-11) and 0345695 (Exp. Date 2021-APR-06). The product was distributed worldwide, including the United States, Canada, and Korea.
The recall was initiated because the products show heavy growth of C. albicans after 24 hours of incubation due to misformulation. The expected reaction is partial inhibition after 18-48 hours of incubation. This excessive fungal growth reduces the identification of Neisseria, which may contribute to a delay in time to definitive diagnosis or a delay in proper treatment.
Healthcare facilities and laboratories should stop using the affected lots and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 15,550
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: 0317559 Exp. Date 2021-MAR-11
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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