Gen Probe Inc Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
Brand
Gen Probe Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lots affected 305025 308126 309091 311067 308184 312083 403055 404065 405079 406083 406218 306299 308125 309092 308185 308124 310115 306150 309093 305165 311069 312146 401048 403054 403099 404084 406084 312146R 307177 305027 308183 3010378 311066 401104 403084 405074 307177B 305027B 308183B 310378B 305027C 311066B 311066C 401104B 403084B 405074B
Gen Probe Inc is recalling Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001, due to Reduced stability. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: distribution information.
Reason for Recall
As stated by FDA
Reduced stability
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026