• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall AccuProbe MYCOBACTERIUM AVIUM COMPLEX IDENTIFICATION TEST

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 1 Recall
AccuProbe MYCOBACTERIUM AVIUM COMPLEX IDENTIFICATION TEST
see related information
Date Posted March 10, 2011
Recall Status1 Terminated on June 08, 2011
Recall Number Z-1437-2011
Recall Event ID 55432
Premarket Notification
510(K) Number
K921435 
Product Classification Dna-Reagents, Mycobacterium Spp. - Product Code LQF
Product Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.
Code Information Lots (batches): 555767
Recalling Firm/
Manufacturer
Gen-Probe Inc
10210 Genetic Center Dr
San Diego, California 92121
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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.
Quantity in Commerce 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, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LQF and Original Applicant = GEN-PROBE, INC.
-
-