Recall Z-1072-04 ยท NDZ Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Gen Probe Inc
Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
| Date | Jul 20, 2004 (initiated Jun 11, 2004) |
| Status | Terminated |
| Reason | Reduced stability |
| Root cause | Other |
| Action | Firm notified all customers by fax and/or overnight letter on June 11, 2004. The notice indicated that users can continue to the MTD product provided that teh Specimen Processing positive cell controls are used according to package insert instructions and valid assay results are obtained. The affected MTD Enzyme Reagent will be replaced with a new lot of reagent. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.