An FDA-recorded root-cause determination. The FDA lists 39 recalls with this root cause since 2025. Most recent report: Apr 22, 2026.
Devices which did not meet internal quality specifications were inadvertently distributed.
Potential exposure of rodents and rodent activity in the distribution center.
Potential exposure of rodents and rodent activity in the distribution center.
Potential exposure of rodents and rodent activity in the distribution center.
Potential exposure of rodents and rodent activity in the distribution center.
Potential exposure of rodents and rodent activity in the distribution center.
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed.…
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.