The Recall Desk
ModerateFDA (Devices)·Z-1643-2022·Announced 2022-09-07

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.

What this means for you

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
Hazard
  • temperature-excursion
  • product-stability-compromise

Distribution

Distributed in 7 states:

  • AL
  • CA
  • DC
  • GA
  • IN
  • OR
  • WA