Z-1438-2011

Mycobacterium Tuberculosis Complex Culture Identification Test, 2860

Name: Z-1438-2011 Mycobacterium Tuberculosis Complex Culture Identification Test, 2860
Creator: Gen-Probe Inc
Published: 2008-12-30
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2008-12-30 / Terminated / root cause: manufacturing process

FDA source

Gen-Probe Inc began a recall of Mycobacterium Tuberculosis Complex Culture Identification Test, 2860 on 2008-12-30. The reason FDA records is "This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1438-2011
Status: Terminated
Initiated: 2008-12-30
Posted: 2011-03-10
Terminated: 2011-06-08
Recalling firm: Hologic, Inc.
Product: Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.
Product code: LQF Dna-Reagents, Mycobacterium Spp.
Reason for recall: This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result. With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the amount destroyed on the Customer Response Form. Gen-Probe should be updated via phone, fax, and email information. Customers should then sign and return the completed form to Gen-Probe via fax to 858-410-8250, or scanned and emailed to [email protected]. The Technical Support team should be contacted for replacement kits. Technical Support was also available for additional information at 888-484-4747 or [email protected].
Quantity in commerce: 1293 kits
Distribution: Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
Product codes and lots: Lots (batches): 554628, 555170, 556204 (Foreign Lot): 554840

Product code LQF

K896493Class IAccuprobe Mycobacterium Tuberculosis Complex TestGen-Probe, Inc. / cleared 1990-04-11

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)