Luminex Corporation Recall 88423
Description: Verigene EP Amplification Reagent Kit Test
Luminex Corporation Recall 88423 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2451-2021 |
| Event ID | 88423 |
| Event Description | Verigene EP Amplification Reagent Kit Test |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey. |
| Quantity | 4579 kits |
| Recall Reason | There is potential for false positive results. |
| Device Classification | 20210922 |
| Device 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 |
| Center Classification Date | 20210910 |
| Recall Initiation Date | 20210803 |
| Recalling Firm | Luminex Corporation |
| Initial Notification | Letter |
| Similar To |