Recall Z-1661-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1661-2018
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: K060385. Product: Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE). 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

K060385 — EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENTDade Behring, Inc.·cleared 2006-04-06

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

Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

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.