Remel Recalls Oxoid Nitrocefin In Vitro Diagnostic Reagents
Remel Inc is recalling Oxoid Nitrocefin reagents because individual bottles may produce weak reactions, leading to delayed or false negative beta-lactamase 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, and the hazard involves potential false negative diagnostic results without reports of direct physical injury or hospitalization, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Remel Inc is voluntarily recalling two units of Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C. This in vitro diagnostic product is used for the rapid chromogenic detection of beta-lactamase activity in bacterial cells. The specific lot number is 1717357, with an expiration date of August 31, 2017.
The recall was initiated because individual bottles of the product may produce weak beta-lactamase reactions. The use of these affected units may result in delayed or false negative reporting of test results.
The affected units were imported and distributed domestically in Missouri. Users of this product should stop using the recalled lot and contact Remel Inc for further instructions or replacement.
The recalled product
- Product
- Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 2
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 1717357 Exp: 31Aug2017
Distribution
Distributed in 1 state:
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