Recall Z-1838-2019— Microbiologics Inc

Name: FDA recall Z-1838-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-16

Class III · Ongoing

Class III FDA medical device recall by Microbiologics Inc, initiated 2019-05-16. It names one FDA 510(k) clearance: K190463. Product: Cepheid Xpert C. difficile/Epi Control Panel. Reason: Product is labeled with expiration date of 2021-10-31, should be 2021-03-31..

Recalling firm: Microbiologics Inc
Classification: Class III
Status: Ongoing
Initiated: 2019-05-16
Firm location: Saint Cloud, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K190463 — Cepheid Xpert C. difficile/Epi Control PanelMicrobiologics, Inc.·cleared 2019-04-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cepheid Xpert C. difficile/Epi Control Panel

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.