CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report

RAPIDLab 1245 Blood Gas Analyzer recalled

Siemens Healthcare Diagnostics is recalling RAPIDLab 1245 Blood Gas Analyzer, distributed nationwide in the US. The recall was initiated on 16 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units affected

Quantity recalled138

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2929-2018
FDA event ID: 80516
Recalling firm: Siemens Healthcare Diagnostics, Newark, DE
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2018
FDA classified: 24 Aug 2018
Reported: 5 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

16 Jul 2018	Recall initiated by company
24 Aug 2018	Classified by FDA	+39 days
5 Sep 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution. Worldwide foreign distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All units affected

Where was it sold?

Nationwide distribution. Worldwide foreign distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 80516

This product is part of a recall event; the main page for the event is RAPIDLab 1265 Blood Gas Analyzer recalled.

Reported	Class	Recall	Company	Reason	Where
5 Sep 2018	CLASS II	RAPIDLab 1265 Blood Gas Analyzer recalled	Siemens Healthcare Diagnostics	Other	Nationwide
5 Sep 2018	CLASS II	RAPIDPoint 500 Blood Gas Analyzer recalled	Siemens Healthcare Diagnostics	Other	Nationwide
5 Sep 2018	CLASS II	RAPIDPoint 405 Blood Gas Analyzer recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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