VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnost
FDA device recall Z-0445-2019 · posted 2018-11-10 · Terminated
Recall details
- Recalling firm
- Luminex Corporation
- Reason for recall
- Potential to lead to a false negative results.
- Action taken
- On September14, 2018, Luminex sent Urgent Customer Advisory Notifications to their consignees. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Experience Team.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- PAM
- Quantity affected
- 12,700 trays
- Distribution
- Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX
- Date initiated
- 2018-09-14
- Date posted
- 2018-11-10
- Date terminated
- 2021-04-28
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 |