Respiratory Pathogens Flex (RP Flex) Amplification Tray 20-011-024

• • Ongoing Z-1092-2022 FDA Class II ·initiated 5 Apr 2022 ·via K143653, on the same 510(k)

  Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

• • Ongoing Z-2006-2021 FDA Class II ·initiated 30 Oct 2020

  Potential for a false-negative result.

• • Ongoing Z-0054-2021 FDA Class II ·initiated 10 Dec 2018

  No results/incorrect results due to failure of the hybridization heater.

• • Terminated Z-0476-2021 FDA Class II ·initiated 13 Oct 2020 ·via K143653, on the same 510(k)

  Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.

• • Terminated Z-0477-2021 FDA Class II ·initiated 13 Oct 2020 ·via K143653, on the same 510(k)

  Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Trade Name

Respiratory Pathogens Flex (RP Flex) Amplification Tray

Generic Name

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Model / Reference

20-011-024

Primary DI / UDI-DI

00857573006324

510(k) Number

K143653 ↗

FDA Product Code

OZE, OEM, OCC, OEP, OZZ, OOU

GMDN Term

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Device Class

Class II

Regulation Number

866.3980

Commercial Distribution

Not in Commercial Distribution

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