# FDA recall Z-0830-2020

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2019-07-22.

## Product

Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells  SMN: 10325366

## Reason for recall

Homocysteine Assay May Cause Elevated Results in the Folate Assay

## Distribution

Nationwide  Foreign:  Armenia¿¿¿¿¿¿¿¿  Austria¿¿¿¿¿¿¿¿  Bahrain¿¿¿¿¿¿¿¿  Belgium¿¿¿¿¿¿¿¿  Bosnia¿Herzeg.¿  Czech¿Republic¿  Denmark¿¿¿¿¿¿¿¿  Egypt¿¿¿¿¿¿¿¿¿¿  France¿¿¿¿¿¿¿¿¿  Georgia¿¿¿¿¿¿¿¿  Germany¿¿¿¿¿¿¿¿  Greece¿¿¿¿¿¿¿¿¿  Hungary¿¿¿¿¿¿¿¿  Iran¿¿¿¿¿¿¿¿¿¿¿  Ireland¿¿¿¿¿¿¿¿  Israel¿¿¿¿¿¿¿¿¿  Italy¿¿¿¿¿¿¿¿¿¿  Jordan¿¿¿¿¿¿¿¿¿  Lithuania¿¿¿¿¿¿  Nepal¿¿¿¿¿¿¿¿¿¿  Netherlands¿¿¿¿  Norway¿¿¿¿¿¿¿¿¿  Pakistan¿¿¿¿¿¿¿  Poland¿¿¿¿¿¿¿¿¿  Portugal¿¿¿¿¿¿¿  Qatar¿¿¿¿¿¿¿¿¿¿  Romania¿¿¿¿¿¿¿¿  Russian¿Fed.¿¿¿  Serbia¿¿¿¿¿¿¿¿¿  Slovakia¿¿¿¿¿¿¿  Slovenia¿¿¿¿¿¿¿  Spain¿¿¿¿¿¿¿¿¿¿  Sudan¿¿¿¿¿¿¿¿¿¿  Sweden¿¿¿¿¿¿¿¿¿  Switzerland¿¿¿¿  Turkey¿¿¿¿¿¿¿¿¿  U.A.E.¿¿¿¿¿¿¿¿¿  United¿Kingdom¿  Vatikancity¿¿¿¿

## Key facts

- **Recall number:** Z-0830-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-22
- **Report date:** 2020-01-29
- **Termination date:** 2025-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0830-2020

## Citation

> AI Analytics. FDA recall Z-0830-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0830-2020. Source: US FDA. Licensed CC0.

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