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 3 Device Recall Vergene GramPositive Blood Culture Nucleic Acid Test (BCGP)

  • 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 3 Device Recall Vergene GramPositive Blood Culture Nucleic Acid Test (BCGP)see related information
Date Initiated by FirmDecember 26, 2018
Date PostedFebruary 11, 2019
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-0822-2019
Recall Event ID 81890
510(K)NumberK122514 
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
ProductVergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.
Code Information UDI: 00857573006287, Lots: 110318018C, 111018018D
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information ContactLuminex Global Support
877-785-2323
Manufacturer Reason
for Recall		On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm, Luminex, notified the consignees by email with a letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 12/20/2018 on 12/26/2018. The letter described the product, problem and actions to be taken. The customers were instructed to: Please check your VERIGENE BC-GP Utility Kit inventory to determine if you have any of the listed products; if product(s) is (are) located within your inventory, please follow the instructions and information about destroying any found recalled product at your facility, and complete and return Acknowledgment and Receipt form an email, and send it on or before January 15, 2019 to support@luminexcorp.com or by mail to: Luminex Corporation Attn: Global Support Services 12201 Technology Boulevard Suite 130 Austin, TX 78727 The firm expanded the recall to include one new lot and notified the consignees on 01/17/2019. This lot was to be destroyed. Please call the Luminex-Global Support Services with any questions or concerns at 1-877-785-2323 (U.S. and Canada) (24 hours/7days); +1-512-381-4397 (Outside U.S. and Canada) (24 hours/7days) or email support@luminexcorp.com.
Quantity in Commerce1132 carriers
DistributionWorldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = PAM
-
-