Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

FDA Recall Z-0982-2019 · Posted 2019-03-07

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodePMN
Date Initiated2019-01-31
Date Terminated2020-06-09
Product Quantity704 units

Reason for Recall

Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

Firm Action

On about 01/31/2019, Microbiologics notified customers via an "Important Medical Device Correction" letter, sent through email. The letter notified customers of the change in expiration date, instructed customers to update their records with the provided new expiration date, to not use the product after the expiration date, and to complete and return the "MEDICAL DEVICE CORRECTION CUSTOMER RESPONSE FORM." For questions, contact Technical Support at 1-320-229-7064 or [email protected].

Root Cause

Error in labeling

Distribution Pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden, Switzerland, United Kingdom.

Official Source

View FDA Recall →

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

↑