# FDA recall Z-1651-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2017-06-29.

## Product

Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (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.

## 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¿¿¿¿¿¿  Luxembour

## Key facts

- **Recall number:** Z-1651-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-29
- **Report date:** 2018-05-16
- **Termination date:** 2020-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2018

## Citation

> AI Analytics. FDA recall Z-1651-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1651-2018. Source: US FDA. Licensed CC0.

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