EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vit...
FDA Device Recall #Z-0697-2016 - Class II, December 28, 2015
Recall Summary
| Recall Number | Z-0697-2016 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 28, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Phadia Ab |
| Location | Uppsala, N/A |
| Product Type | Devices |
| Quantity | 76 |
Product Description
EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
Reason for Recall
All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.
Distribution Pattern
US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
Lot / Code Information
Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
Other Recalls from Phadia Ab
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0783-2024 | Class II | EliA GBM Wells, Material Number 14551401, for P... | May 24, 2023 |
| Z-2397-2019 | Class II | Phadia" 1000 Model # 12-3800-01 Product Usa... | Jul 9, 2019 |
| Z-1907-2019 | Class II | EliA RF IgM Well, REF 14-5600-01 Product Usa... | May 10, 2019 |
| Z-1276-2018 | Class II | Phadia Prime software, article number 12-4101-0... | Nov 20, 2017 |
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.