# FDA recall Z-2929-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-07-16.

## Product

RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393     Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.

## Reason for recall

Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.

## Distribution

Nationwide distribution. Worldwide foreign distribution.

## Key facts

- **Recall number:** Z-2929-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-16
- **Report date:** 2018-09-05
- **Termination date:** 2020-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2929-2018

## Citation

> AI Analytics. FDA recall Z-2929-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2929-2018. Source: US FDA. Licensed CC0.

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