Microbiologics Recalls Cepheid Xpert C. difficile/Epi Control Panel Due to Labeling Error
Microbiologics Inc is recalling 22 units of the Cepheid Xpert C. difficile/Epi Control Panel because the expiration date is incorrectly labeled as 2021-10-31 instead of 2021-03-31.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.
Plain-English summary
Microbiologics Inc is recalling 22 units of the Cepheid Xpert C. difficile/Epi Control Panel. The recall was initiated because the product is labeled with an expiration date of 2021-10-31, whereas the correct expiration date is 2021-03-31.
The affected units are identified by UDI 70845357041370 and Lot Number 8200-26. These products were distributed in New York, Minnesota, North Carolina, Texas, Georgia, Missouri, Pennsylvania, Tennessee, New Hampshire, Ohio, and Colorado.
Consumers and healthcare facilities should check their inventory for this specific lot number and UDI. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the incorrect expiration date may lead to the use of expired testing controls.
The recalled product
- Product
- Cepheid Xpert C. difficile/Epi Control Panel
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 22
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: 70845357041370
- Lot Number 8200-26
Distribution
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