Sekisui OSOM BVBLUE Bacterial Vaginosis Control Kit recalled due to temperature exposure
A Sekisui Diagnostics control kit for bacterial vaginosis testing was recalled after exposure to temperatures below the validated storage range for up to 60 minutes due to refrigerator mechanical failure.
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 medical device recall based on a storage temperature excursion with no reported illnesses or injuries. The recall is precautionary in nature, based on potential but unconfirmed product compromise due to improper storage conditions.
Plain-English summary
Sekisui Diagnostics Control Kit OSOM® BVBLUE® Bacterial Vaginosis is being recalled. The product is manufactured by Mckesson Medical-Surgical Inc. Corporate Office.
On January 8, 2024, a temperature excursion occurred at a facility storage location due to mechanical failure of a walk-in refrigerator. Temperatures fell below the validated storage range of 35.6 to 46.4 degrees Fahrenheit (2 to 8 degrees Celsius) for up to 60 minutes. This exposure may compromise the control kit's performance and reliability.
The affected product lot is CK233 (Catalogue Number 184). Distribution was nationwide in Arizona, Pennsylvania, and Texas.
The recalled product
- Product
- Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- 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 (2)
- Catalogue Number: 184
- Lot No. CK233
Distribution
Part of a larger recall action
This product is one of 5 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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.
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