Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.

FDA device recall Z-1437-2011 · posted 2011-03-10 · Terminated

Recall details

Recalling firm

Gen-Probe Inc

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.

Action taken

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 technicalsupport@genprobe.com. The Technical Support team should be contacted for replacement kits. Technical Support was also available for additional information at 888-484-4747 or technicalsupport@gen-probe.com.

Root cause

Process control

Status

Terminated

Product code

LQF

Quantity affected

311 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, Netherl

Date initiated

2008-12-30

Date posted

2011-03-10

Date terminated

2011-06-08

Location

San Diego, CA

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