Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall AccuProbe GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST

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


New Search Back to Search Results
  Class 1 Device Recall AccuProbe GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST see related information
Date Initiated by Firm December 30, 2008
Date Posted March 10, 2011
Recall Status1 Terminated 3 on June 08, 2011
Recall Number Z-1436-2011
Recall Event ID 55432
510(K)Number K974572  
Product Classification Streptococcal Reagents DNA-Probe - Product Code MDK
Product Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
Code Information Lots (batches): 554077, 551345, 556007, 556185, 555368, 554864, 556421, 555167, 555096, 555166, 556184, and 554524 (Internationally): 554076, 555622
Recalling Firm/
Manufacturer		 Gen-Probe Inc
10210 Genetic Center Dr
San Diego CA 92121
For Additional Information Contact
858-410-8703
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		 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 1055 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MDK and Original Applicant = CHUGAI PHARMACEUTICALS CO., LTD.
-
-