The Recall Desk
LowFDA (Devices)·Z-1838-2019·Announced 2019-06-26

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.

What this means for you

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
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

Distributed in 11 states: