Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negatives
Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement SR0110A because it may fail to recover Legionella pneumophila, leading to false negative test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 does not report any hospitalizations or injuries. The hazard is a diagnostic error (false negatives) rather than a direct physical injury, fitting the criteria for a moderate severity score.
Plain-English summary
Remel Inc is recalling 24 packs of Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials. The product is identified by Lot No. 1545171. The label identifies the responsible firm as Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
The recall was initiated because the use of this product may not provide adequate recovery of Legionella pneumophila. This deficiency could result in false negative identification of the bacteria, potentially compromising the accuracy of laboratory testing.
The affected product was distributed in the United States to the states of Michigan, North Dakota, South Carolina, Tennessee, and Texas. Users of this product should stop using it and contact Remel Inc for further instructions.
The recalled product
- Product
- Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
- Manufacturer
- Remel Inc
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 No. 1545171
Distribution
Related recalls
Same manufacturer · Remel Inc
See all →- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- HighYeastone Broth recalled because it may report incorrect susceptibility results
FDA (Devices) · 2026-04-22
- SevereRemel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery
FDA (Devices) · 2026-03-04
- ModerateCulture media recalled over contamination that may darken the broth
FDA (Devices) · 2025-12-03
- HighStrep Selective II Agar plates may carry Listeria monocytogenes contamination
FDA (Devices) · 2025-08-06
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighHeparin antibody test kits recalled over a defect producing negative results
FDA (Drugs) · 2026-01-21
Similar recalls
- HighRemel Legionella Growth Supplement Recalled for Potential False Negative Results
FDA (Devices) · 2014-11-19
- HighRemel Recalls Oxoid Legionella BCYE Growth Supplement Due to Contamination
FDA (Devices) · 2014-03-05
- HighRemel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negative Risk
FDA (Devices) · 2014-12-17
- HighRemel Recalls Oxoid Legionella Latex Test Due to False Negative Risk
FDA (Devices) · 2014-04-30
- ModerateRemel Recalls Oxoid Legionella Latex Test Due to False Negative Results
FDA (Devices) · 2014-12-03
- HighRemel Lyophilized Growth Supplement Recalled for Microbial Contamination
FDA (Devices) · 2013-02-20