Cell culture medium recalled for improper storage temperature conditions
Oxford Immunotec is recalling 6 units of AIM-V Medium (Lot 100380) distributed in seven U.S. states due to equipment failure causing storage outside the validated 2-8°C temperature range for longer than the validated duration.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is potential product degradation due to storage conditions outside validated parameters, which is theoretical and precautionary rather than an immediate safety threat. This fits the rubric criterion for voluntary precautionary recalls with low-risk contamination.
Plain-English summary
Oxford Immunotec Ltd is recalling 6 units of AIM-V Medium (Model/Catalog Number AV.200/500, Lot 100380). The recall affects customers in the following U.S. states: Alabama, California, District of Columbia, Georgia, Indiana, Oregon, and Washington.
The recall was initiated due to equipment failure that caused the affected products to be stored at temperatures outside the validated range of 2-8 degrees Celsius for a period longer than the validated storage time. This deviation from storage specifications could have compromised the product's stability and effectiveness.
Laboratories and research facilities that received affected units should stop using them immediately and contact Oxford Immunotec Ltd for instructions on product return or disposal. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- AIM-V Medium REF AV.200/500
- Manufacturer
- OXFORD IMMUNOTEC LTD
- Affected units
- 6
Distribution
Part of a larger recall action
This product is one of 3 recalled by OXFORD IMMUNOTEC LTD 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.
See all 3 products in this recall →Related recalls
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