Hologic Panther System Recalled for Incorrect Incubator Installation
Hologic is recalling one Panther System unit in Indiana because an incorrect incubator was installed, which may have led to incorrect Aptima Combo 2 assay results.
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: The recall is classified as FDA Class II. The hazard involves potential incorrect diagnostic results due to an installation error, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
Hologic, Inc. is recalling one unit of the Panther(R) System, Catalog Number 902615, for in vitro diagnostic use. The recall is limited to a specific unit with Serial Number 20900001124 that was distributed in Indiana.
The recall was initiated because an incorrect incubator was installed on the device. This installation error potentially led to incorrect results for the Aptima Combo 2(R) assay (AC2).
No specific instructions for consumers or healthcare providers are provided in the source text regarding how to handle the device or affected test results.
The recalled product
- Product
- Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
- Manufacturer
- Hologic, Inc
- Affected units
- 1
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)
- Serial Number 20900001124
Distribution
Distributed in 1 state:
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