Recall Z-0982-2019 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Microbiologics Inc
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
| Date | Mar 7, 2019 (initiated Jan 31, 2019) |
| Status | Terminated |
| Reason | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months. |
| Root cause | Error in labeling |
| 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 techsupport@microbiologics.com. |
| Quantity | 704 units |
| Distribution | 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.