Microbiologics Recalls Cepheid Xpert SA Nasal Control Panels for Shelf Life Error
Microbiologics is recalling 235 units of Cepheid Xpert SA Nasal Complete Control Panels due to incorrect shelf life labeling.
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, which typically corresponds to a moderate severity score. The hazard is a labeling error (incorrect shelf life) with no reported illnesses or injuries, fitting the criteria for a moderate risk.
Plain-English summary
Microbiologics Inc is recalling 235 units of the Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) because the product has an incorrect shelf life. The affected lots are 8196-04, 8196-05, 8196-06, 8196-07, 8196-08, 8196-09, 8196-10, and 8196-14.
The product was distributed nationwide in the United States and internationally to Australia, Chile, Germany, New Zealand, and the United Kingdom. On April 9, 2019, Microbiologics sent emails to direct US consignees requesting them to complete a Medical Device Correction Form indicating how much product they had on hand.
This is a Class II recall. No illnesses or injuries have been reported. Users should contact Microbiologics for instructions on how to return or dispose of the affected product.
The recalled product
- Product
- Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 235
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 (6)
- 8196-05
- 8196-06
- 8196-07
- 8196-08 8196-09
- 8196-10
- and 8196-14.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Microbiologics Inc 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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