Recall Z-2451-2021
Luminex Corporation · initiated August 3, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Verigene EP Amplification Reagent Kit Test
Codes / lots: Model: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023; Lots: 111620023A 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F
Reason for recall
There is potential for false positive results.
FDA-determined cause: Process control
Action taken
A customer letter was issued to notify consignees of the recall dated 08/03/2021. Customers are advised to notify Luminex if they are impacted by the recall and Luminex will facilitate replacement of the product. Customers are asked to destroy impacted product and document actions on a return response form.
Details
- Recall number
- Z-2451-2021
- Initiated
- August 3, 2021
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Quantity
- 4579 kits
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
- Recalling firm
- Luminex Corporation, Northbrook, IL