FDA Medical Device Recalls (openFDA)
Microbiologics Inc: Cepheid Xpert C. difficile/Epi Control Panel
- Recall number
- Z-1838-2019
- Recalling firm
- Microbiologics Inc
- Product
- Cepheid Xpert C. difficile/Epi Control Panel
- Status
- Open, Classified
- Initiated
- 2019-05-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
- 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
- 22 units
- Distribution
- NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
- Lot, serial or model codes
- UDI: 70845357041370, Lot Number 8200-26
- 510(k) numbers
- ["K190463"]
- PMA numbers
- not on file
- Product code
- PMN
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28