FDA Medical Device · Z-1649-2018

Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Class II · Terminated

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.

Affected lots / codes — check yours against thisAll lots

Recalling firm: Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 37,923
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¿…
Recall initiated: June 29, 2017
Classified: May 4, 2018
Terminated: April 23, 2020
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1649-2018%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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