Mycobacterium Tuberculosis Complex Culture Identification… recallZ-1438-2011 · Gen-Probe Inc · initiated Dec 30, 2008

Terminated All recalls posted in March 2011

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Gen-Probe Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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].

Recall details

Recall number: Z-1438-2011
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Dec 30, 2008
Posted by the FDA: Mar 10, 2011
Recalling firm: Gen-Probe Inc
Quantity: 1293 kits
Product code: LQF
FDA submissions: K896493
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 description

Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

Code information (models, lots, serial numbers)

Lots (batches): 554628, 555170, 556204 (Foreign Lot): 554840

Other devices under the same FDA submission

1 device cleared under K896493 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

ACCUPROBE® KIT,ACCUPROBE,M. TUBERCULOSIS
Hologic, Inc. · DNA-REAGENTS, MYCOBACTERIUM SPP.
1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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