Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
FDA device recall Z-1072-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Gen Probe Inc
- Reason for recall
- Reduced stability
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NDZ
- Date initiated
- 2004-06-11
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-09
- Location
- San Diego, CA
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