RecallRadar

FDA Device recall Z-1838-2019

Cepheid Xpert C. difficile/Epi Control Panel

On 2019-06-26 the FDA classified a Class III recall of Cepheid Xpert C. difficile/Epi Control Panel by Microbiologics, citing product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1838-2019
ClassificationClass III
Statusongoing
Initiated2019-05-16
Published2019-06-26
Last updated2026-09-13 11:55 UTC
CompanyMicrobiologics
DistributionCO, GA, MN, MO, NC, NH, NY, OH, PA, TN, TX

Product

Cepheid Xpert C. difficile/Epi Control Panel

Reason

Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

Identifiers

code_infoUDI: 70845357041370, Lot Number 8200-26

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1838-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.