Z-1655-2018Class II

Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics...

Name: Z-1655-2018 Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-06-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-06-29 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) on 2017-06-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1655-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Posted: 2018-05-04
Terminated: 2020-04-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Product code: JIF Enzymatic Method, Ammonia
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.
Root cause tag: design
FDA root cause: Device Design
Action: Letters were sent to consignees with the following instructions: " Please review this letter with your Medical Director. " Venipuncture should occur before drug administration of Sulfasalazine or Sulfapyridine as indicated above under Reason For Correction. Baseline assay values before administration of Sulfasalazine or Sulfapyridine therapy would not be affected. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " If you have received any complaints of illness or adverse events associated with the products listed in Table 1 or 2, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 34,590
Distribution: 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
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1655-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1646-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1647-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1648-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1649-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1650-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1651-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1652-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1653-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1654-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1655-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1656-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1657-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1658-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1659-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1660-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1661-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1662-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code JIF

K123677Class IDimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)Siemens Healthcare Diagnostics / cleared 2013-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)