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Verigene CDF Nucleic Acid Test, Part No. 30-002-22 recallZ-1334-2022 · Luminex Corporation · initiated Jun 17, 2022

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The firm notified its consignees of the recall by letter on 06/17/2022. The letter explained the issue and provided the following actions be taken: "Customer Action: 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected VERIGENE Stool Sample Preparation Kits in your possession (reference Tables 1 & 2 for impacted kit lots), please contact Luminex Global Support Services at [email protected] to arrange for replacement and confirm the disposal of any remaining kits in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results for VERIGENE Enteric Pathogens Nucleic Acid test and VERIGENE CDF Nucleic Acid test from 3/25/2021 to11/29/2021. If you have encountered a false negative result with a patient sample tested with kits received during this time frame, please contact Luminex Global Support Services at [email protected] 4. Distribute the notification to any individuals within your organization who need to be made aware of this recall. 5. Please complete the Acknowledgement & Receipt Form and return it to Luminex Technical Support. 6. For those with complaints, questions, or concerns, please contact Luminex Global Support Services at 1-877-785-2323 (U.S. and Canada) or +1-512-381-4397 (Outside U.S. and Canada). 7. Reports can also be made directly to the FDA MedWatch Serious Injury Reporting Program online by completing and submitting the report online at: www.fda.gov/medwatch/report, or by regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178."

Recall details

Recall number
Z-1334-2022
Status
Open, Classified
Initiated by the company
Jun 17, 2022
Recalling firm
Luminex Corporation
Quantity
296 units
Product code
OZN
Distribution
Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

Product description

Verigene CDF Nucleic Acid Test, Part No. 30-002-22

Code information (models, lots, serial numbers)

UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 90122).

Sources and updates

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