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.