Verigene EP Amplification Reagent Kit Test
This recall is currently active, issued August 3, 2021. It was issued by Luminex Corporation.
- Company
- Luminex Corporation
- Recall Initiated
- August 3, 2021
- Recall Number
- Z-2451-2021
- Quantity
- 4579 kits
- Firm Location
- Northbrook, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There is potential for false positive results.
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
Lot / Code Info
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
Root 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.