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

FDA device recall Z-0822-2019 · posted 2019-02-11 · Terminated

Recall details

Recalling firm

Luminex Corporation

Reason for recall

On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

Action taken

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 support@luminexcorp.com 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 support@luminexcorp.com.

Root cause

Under Investigation by firm

Status

Terminated

Product code

PAM

Quantity affected

1132 carriers

Distribution

Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.

Date initiated

2018-12-26

Date posted

2019-02-11

Date terminated

2020-08-04

Location

Austin, TX

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