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Terminated

Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

FDA Recall Z-2775-2020 · Posted None

Recalling FirmLuminex Corporation
Recall StatusTerminated
Product CodePAM
Date Initiated2020-06-15
Date Terminated2023-06-30
Product QuantityTotal = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)

Reason for Recall

An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

Firm Action

On 06/10/2020, the firm sent a letter to customers titled, "MEDICAL DEVICE FIELD ACTION", regarding an instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. The firm has developed a software solution that identifies and alerts users to the issue. The firm will contact customers to verify their address to ship the software material and provide installation information. Once the update has been completed, customers need to email a screen shot of the updated software, as well as a completed Notice of Destruction to Global Support Services at [email protected] to complete the upgrade process. The firm is also stating that until the updated software is installed, it is important, and part of good laboratory practice, that the customer follow the specific guidelines indicated in the current package inserts. Specifically, "Not Detected" test results from a positive blood culture should be evaluated further. The sub-culturing of blood cultures is necessary, per the intended use section within the Package Inserts in the Kits. For any questions contact the firm's Global Support Service at: 1.877.785.2323 (US) 1.512.381.4397 (OUS/CANADA) 512.219.5114 [email protected] www.luminexcorp.com

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countries of Austria, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Kuwait, Macau, Mexico, Netherlands, New Zealand, Republic of Russia, Saudi Arabia, Singapore, Spain, Thailand, Turkey, United Arab Emirate, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122514VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTNanosphere, Inc. · 2012-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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