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Open, Classified

Cepheid Xpert C. difficile/Epi Control Panel

FDA Recall Z-1838-2019 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusOpen, Classified
Product CodePMN
Date Initiated2019-05-16
Product Quantity22 units

Reason for Recall

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

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190463Cepheid Xpert C. difficile/Epi Control PanelMicrobiologics, Inc. · 2019-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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