Z-1072-04

Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001

Name: Z-1072-04 Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001
Creator: Gen Probe Inc
Published: 2004-06-11
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2004-06-11 / Terminated

FDA source

Gen Probe Inc began a recall of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001 on 2004-06-11. The reason FDA records is "Reduced stability". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1072-04
Status: Terminated
Initiated: 2004-06-11
Posted: 2004-07-20
Terminated: 2004-09-09
Recalling firm: Hologic, Inc.
Product: Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
Product code: NDZ Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Reason for recall: Reduced stability
FDA 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.
Product codes and lots: 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

Product code NDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)