Remel Neisseria meningitidis Gp C In Vitro Diagnostics Recall
Remel Europe Ltd. is recalling specific lots of Neisseria meningitidis Gp C in vitro diagnostics that fail to meet performance criteria.
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, and the source text describes a performance deviation without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Remel Europe Ltd. is recalling 26 units of Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901. The affected lots are identified by UDI/DI 05056080501161 and include lot numbers 6214791, 6175327, 6148809, and 6002010.
The recall was initiated because certain lots of the product are not performing to the Instructions for Use (IFU) criteria, specifically failing to test positive to ATCC13102 within 60 seconds. This performance issue may affect the accuracy of diagnostic results.
The product was distributed nationwide in the United States. Users of these in vitro diagnostics should stop using the affected lots and contact Remel Europe Ltd. for further instructions or a replacement.
The recalled product
- Product
- Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
- Manufacturer
- Remel Europe Ltd.
- Hazard
- Affected units
- 26
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 (9)
- UDI/DI 05056080501161
- Lot Numbers: 6214791
- exp. 18/03/2025
- 6175327
- exp. 04/12/2027
- 6148809
- exp. 30/09/2027
- 6002010
- exp. 31/07/2027.
Distribution
Distributed nationwide across the United States.
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