Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CD...
FDA Device Recall #Z-1790-2020 — Class II — March 2, 2020
Recall Summary
| Recall Number | Z-1790-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 2, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CSL Behring GmbH |
| Location | Marburg, N/A |
| Product Type | Devices |
| Quantity | 297 PCK US; 1247 PCK OUS |
Product Description
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Reason for Recall
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
Distribution Pattern
IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Taiwan
Lot / Code Information
US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11
Other Recalls from CSL Behring GmbH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2931-2018 | Class II | N Latex CDT Kit | May 31, 2018 |
| Z-0191-2018 | Class II | SIEMENS N/T Protein Control SL for use on the B... | Jun 5, 2017 |
| Z-0190-2018 | Class II | SIEMENS N Protein Standard SL, for use on the B... | Jun 5, 2017 |
| Z-2241-2016 | Class II | Dimension Vista¿ Homocysteine Flex Reagent Cart... | May 17, 2016 |
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.