Recall Z-2776-2020
Luminex Corporation · initiated June 15, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
Codes / lots: Verigene Processor SP, 10-0000-07, GTIN 00840487101483, Serial Numbers: 902, 907, 908, 909, 911, 912, 9098001, 9098002, 9098003, 9098005, 9098006, 9100009, 9100011, 9100012, 9100014, 9121015, 9121017, 9121018, 9121019, 9121021, 9121022, 9135024, 9135026, 9135027, 9135028, 9135029, 9163034, 9163035, 9163038, 9163039, 9163040, 9163041, 9163042, 9163043, 9163044, 9163045, 9163046, 9202047, 9202050, 9202051, 9202052, 9202053, 9202054, 9210055, 9210056, 9210057, 9210058, 9210059, 9210061, 9210062, 9230063, 9230064, 9230065, 9230066, 9230067, 9230068, 9230069, 9230070, 9230074, 9230075, 9255071, 9255072, 9255077, 9255079, 9255080, 9270080, 9270082, 9270084, 9270085, 9270086, 9270087, 9277088, 9277089, 9277090, 9277091, 9277092, 9277093, 9277094, 9288095, 9288096, 9288097, 9288102, 9293103, 9293106, 9293109, 9293111, 9298112, 9298116, 9298117, 9298118, 9313119, 9313120, 9313121, 9313122, 9313123, 9313124, 9320127, 9325138, 9325151, 9325152, 9336144, 9336145, 9336146, 9336147, 9336148, 9336149, 9336150, 9336155, 9336156, 9336157, 9336158, 9350159, 9350160, 9350161, 9350163, 9350164, 9350165, 10014001, 10014003, 10014012, 10035017, 10035105, 10035106, 10043023, 10043024, 10043025…
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.
FDA-determined cause: Device Design
Action taken
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 support@luminexcorp.com 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 support@luminexcorp.com www.luminexcorp.com
Details
- Recall number
- Z-2776-2020
- Initiated
- June 15, 2020
- Terminated
- June 30, 2023
- Product code
- PEN – Gram-Negative Bacteria And Associated Resistance Markers
- Quantity
- Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
- Distribution
- 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…
- Recalling firm
- Luminex Corporation, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2775-2020 Class II | Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic…An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN)… | 06/15/2020Terminated |