Z-1838-2019Class III

Cepheid Xpert C. difficile/Epi Control Panel

Name: Z-1838-2019 Cepheid Xpert C. difficile/Epi Control Panel
Creator: Microbiologics Inc
Published: 2019-05-16
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2019-05-16 / Open, Classified / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of Cepheid Xpert C. difficile/Epi Control Panel on 2019-05-16. FDA classified it as Class III and gives the reason as "Product is labeled with expiration date of 2021-10-31, should be 2021-03-31". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1838-2019
Classification: Class III
Status: Open, Classified
Initiated: 2019-05-16
Posted: 2019-06-18
Recalling firm: Microbiologics, Inc.
Product: Cepheid Xpert C. difficile/Epi Control Panel
Product code: PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Reason for recall: Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall by email on 05/20/2019. The notice requested the consignee relabel the product with the correct date and return the completed response form.
Quantity in commerce: 22 units
Distribution: NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
Product codes and lots: UDI: 70845357041370, Lot Number 8200-26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1838-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1838-2019	Class III	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-18

Product code PMN

K190463Class IICepheid Xpert C. difficile/Epi Control PanelMicrobiologics, Inc. / cleared 2019-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)