Recall Z-1648-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1648-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-29

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-06-29, terminated 2020-04-23. It names one FDA 510(k) clearance: K093939. Product: ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics). Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Terminated: 2020-04-23
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K093939 — ADVIA CHEMISTRY SALICYLATE REAGENTSiemens Healthcare Diagnostics·cleared 2010-05-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.