ADVIA Salicylate — Class II medical device recall Z-1648-2018

Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-05-16, distributed in DC, GA, GU, PR. Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere

Recall number	`Z-1648-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States
Recall initiated	2017-06-29
Classified	2018-05-04
Reported by FDA	2018-05-16
Terminated	2020-04-23
Distributed	DC, GA, GU, PR
Countries outside the US	AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VE, VN, ZA
Quantity	1,667
Reason classes	chemical contamination

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1648-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.