Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare D...

FDA Device Recall #Z-1660-2018 — Class II — June 29, 2017

Recall Summary

Recall Number Z-1660-2018
Classification Class II — Moderate risk
Date Initiated June 29, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Healthcare Diagnostics, Inc.
Location Tarrytown, NY
Product Type Devices
Quantity 19,991

Product Description

Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Reason for Recall

Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

Distribution Pattern

Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan Bolivia Albania¿¿¿¿¿¿¿¿ Algeria¿¿¿¿¿¿¿¿ Angola ARGENTINA Armenia AUSTRALIA Austria¿¿¿¿¿¿¿¿ Azerbaijan Bahamas Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belarus¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Bulgaria¿¿¿¿¿¿¿ Cambodia Canada Canary islands Chile China Colombia Costa Rica Croatia¿¿¿¿¿¿¿¿ Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Ecuador Egypt¿¿¿¿¿¿¿¿¿¿ El Salavador Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Guatemala Honduras Hong Kong Hungary¿¿¿¿¿¿¿¿ Iceland India Indonesia Iraq Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ japan Jordan Kazakhstan¿¿¿¿¿ Korea Kuwait Latvia¿¿¿¿¿¿¿¿¿ Lebanon Lithuania¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Macedonia Malaysia Mali Malta¿¿¿¿¿¿¿¿¿¿ Mexico Morocco¿¿¿¿¿¿¿¿ Myanmar Nepal Netherlands¿¿¿¿ New Zealand Nicaragua Norway¿¿¿¿¿¿¿¿¿ Oman Pakistan¿¿¿¿¿¿¿ Paraguay Peru Philippines Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Saudi Arabia Senegal Serbia¿¿¿¿¿¿¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ South Africa South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tajikistan Thailand Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ Turkmenistan¿¿¿ United Arab Emerites¿¿¿¿¿¿ United¿Kingdom¿ Uruguay¿¿¿¿¿¿¿¿ Uzbekistan Vatikancity¿¿¿¿ Venezuela Vietnam Yemen

Lot / Code Information

All lots

Other Recalls from Siemens Healthcare Diagnostics, Inc.

Recall # Classification Product Date
Z-1484-2026 Class II Atellica CH Urine Albumin (UAlb). Material Numb... Jan 20, 2026
Z-0491-2026 Class II IMMULITE 2000 Oak Mix Specific Allergen; Sieme... Oct 6, 2025
Z-0492-2026 Class II 3gAllergy Specific IgE Universal Kit; Kit Comp... Oct 6, 2025
Z-0493-2026 Class II Food Panel 3 Specific Allergen; Siemens Materi... Oct 6, 2025
Z-0366-2026 Class II Assay: IMMULITE 2000 Intact PTH; Test Code: iP... Sep 22, 2025

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.

More from Siemens Healthcare Dia... Recalls by Firm Recall Reasons Device Safety Stats