ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
Enforcement
- Recall Number
- Z-1646-2018
- Event ID
- 79225
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- May 16, 2018
- Initiation Date
- June 29, 2017
- Classification Date
- May 4, 2018
- Termination Date
- April 23, 2020
- Address
- 511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States
Description
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
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.
All lots
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
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