Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 recallZ-0822-2019 · Luminex Corporation · initiated Dec 26, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
FDA root cause category: Under Investigation by firm
What the company is doing
The 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 [email protected] 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 [email protected].
Recall details
- Recall number
- Z-0822-2019
- Status
- Terminated
- Initiated by the company
- Dec 26, 2018
- Posted by the FDA
- Feb 11, 2019
- Recalling firm
- Luminex Corporation
- Quantity
- 1132 carriers
- Product code
- PAM
- FDA submissions
- K122514
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
Product description
Vergene 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 (models, lots, serial numbers)
UDI: 00857573006287, Lots: 110318018C, 111018018D
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gram-Positive Blood Culture (BC-GP) Utility Tray 20-011-018Nanosphere, Inc. · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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