Recall Z-0498-2022
Luminex Corporation · initiated April 16, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Codes / lots: Lot number AB1703A
Reason for recall
Impacted lot may leak inside the ARIES instrument.
FDA-determined cause: Equipment maintenance
Action taken
On 04/16/2021, the firm notified affected customers via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated the following: " Please inform all those who need to be aware within your organization of this potential product performance issue. At this time, you should destroy any inventory of these ARIES HSV 1&2 Assays. Please follow the "Steps in Voluntary Recall" directions found on the following pages of this notification. The Acknowledgment and Receipt Form must be completed and returned, even if you do not have any remaining product, by April 26th, 2021. We appreciate your assistance with this matter. Please call Luminex's Global Support Services if you have any questions or concerns. Luminex Global Support Services 1-877-785-2323 (U .S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) support@luminexcorp.com CAN-0282, Rev A
Details
- Recall number
- Z-0498-2022
- Initiated
- April 16, 2021
- Terminated
- September 20, 2024
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- Quantity
- 296 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
- Recalling firm
- Luminex Corporation, Austin, TX