Z-0822-2019Class III

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic...

Name: Z-0822-2019 Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic...
Creator: Luminex Corporation
Published: 2018-12-26
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2018-12-26 / Terminated / root cause: labeling and UDI

FDA source

Luminex Corporation began a recall of 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... on 2018-12-26. FDA classified it as Class III and gives the reason as "On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0822-2019
Classification: Class III
Status: Terminated
Initiated: 2018-12-26
Posted: 2019-02-11
Terminated: 2020-08-04
Recalling firm: Luminex Corporation
Product: 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.
Product code: PAM Gram-Positive Bacteria And Their Resistance Markers
Reason for recall: On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 1132 carriers
Distribution: Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
Product codes and lots: UDI: 00857573006287, Lots: 110318018C, 111018018D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0822-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0822-2019	Class III	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-11

Product code PAM

K122514Class IIVerigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestNanosphere, Inc. / cleared 2012-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)