IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-acc...
FDA Device Recall #Z-1316-2014 — Class II — February 3, 2014
Recall Summary
| Recall Number | Z-1316-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 3, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions Diagnostics |
| Location | Flanders, NJ |
| Product Type | Devices |
| Quantity | 1006 units |
Product Description
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Reason for Recall
There is a potential for incorrect results to be reported from processing of a sample tube.
Distribution Pattern
Nationwide and Foreign Distribution.
Lot / Code Information
IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839
Other Recalls from Siemens Medical Solutions Diagnostics
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1660-2015 | Class II | Accessory Kit, Catalog#10282965, #10373217,#102... | Mar 5, 2015 |
| Z-1662-2015 | Class II | Water Feed Kit, Catalog#10288216,#10389714. ... | Mar 5, 2015 |
| Z-1661-2015 | Class II | Direct Water feed Kit, Catalog#10373222 | Mar 5, 2015 |
| Z-1658-2015 | Class II | Water bottles, Catalog#10380062, #10291586. ... | Mar 5, 2015 |
| Z-1663-2015 | Class II | Liquid Waste Bottle Kit, Catalog#10386287. T... | Mar 5, 2015 |
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.