Thermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled
Remel, Inc. is recalling one lot of Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth due to off-color that may affect performance of this in-vitro diagnostic device.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a performance issue (off-color) that is theoretical rather than confirmed to cause harm.
Plain-English summary
Remel, Inc. is recalling Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410, a clinical in-vitro diagnostic device used in laboratory testing. The product may have an off-color affecting performance.
The affected product is lot 226414, UDI/DI 848838018855, with 70 units distributed. Distribution included the U.S. states of Alabama, Georgia, Kentucky, and Virginia, as well as Canada and the United Kingdom.
If you have this product, contact Remel, Inc. for further instructions regarding the recalled lot.
The recalled product
- Product
- Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
- Manufacturer
- Remel, Inc
- Hazard
- performance-defect
- color-anomaly
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 (2)
- UDI/DI 848838018855
- lot 226414
Distribution
Distributed nationwide across the United States.
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