Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small ...
FDA Device Recall #Z-1707-2020 — Class II — March 16, 2020
Recall Summary
| Recall Number | Z-1707-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 16, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Life Technologies Corporation |
| Location | Frederick, MD |
| Product Type | Devices |
| Quantity | 79 units |
Product Description
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
Reason for Recall
Extended Expiration Date prior to clearance
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
Lot Codes: S119_2174740* S119_2108429* P119_2149308 N119_2078115 S218_2069396 V118_1991155 T118_1990947 S217_2008385 S118_1988604 P118_1996942 N118_1974439 S117_1988308 * Mislabeled with a 24-month expiration date. However, the approved shelf life of the vials is also 9 months. Please note, the kit level labelling for the two impacted lots of Ion Torrent Dx No Template Control kit shows a 12-month expiration date, which is also incorrect UDI: (01)10190302006156
Other Recalls from Life Technologies Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1426-2024 | Class II | Torrent Suite Dx Software versions 5.14 and ear... | Feb 7, 2024 |
| Z-2978-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Bi... | Aug 6, 2020 |
| Z-2979-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Bi... | Aug 6, 2020 |
| Z-1706-2020 | Class II | Oncomine Dx Target Test RNA/DNA Panel- IVD for ... | Mar 16, 2020 |
| Z-1704-2020 | Class II | Oncomine Dx Target Test DNA Control-IVD for det... | Mar 16, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.