# FDA recall Z-0971-2019

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2019-01-02.

## Product

ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31    The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

## Reason for recall

Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.

## Distribution

Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.

## Key facts

- **Recall number:** Z-0971-2019
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-02
- **Report date:** 2019-03-13
- **Termination date:** 2021-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2019

## Citation

> AI Analytics. FDA recall Z-0971-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0971-2019. Source: US FDA. Licensed CC0.

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