Z-1651-2018 Class II Terminated
FDA device recall Z-1651-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on June 29, 2017 and is designated Class II. 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 dep… The recall status is terminated (terminated April 23, 2020). Affected quantity: 181,072.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- June 29, 2017
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 181,072
Product Description
Reason for Recall
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