Recall Z-1838-2019 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Microbiologics Inc
Cepheid Xpert C. difficile/Epi Control Panel
| Date | May 16, 2019 |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190463 | Cepheid Xpert C. difficile/Epi Control Panel Microbiologics, Inc., Apr 19, 2019 |