CLASS II Device recall · Reported 18 Mar 2015 · FDA Enforcement Report

RAPIDPoint 500 Blood Gas Analyzer recalled

Siemens Healthcare Diagnostics is recalling RAPIDPoint 500 Blood Gas Analyzer, distributed nationwide in the US. The recall was initiated on 30 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers.

Quantity recalled4376 devices

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-1253-2015
FDA event ID: 70203
Recalling firm: Siemens Healthcare Diagnostics, Norwood, MA
Classification: Class II
Status: Terminated
Recall initiated: 30 Dec 2014
FDA classified: 6 Mar 2015
Reported: 18 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

30 Dec 2014	Recall initiated by company
6 Mar 2015	Classified by FDA	+66 days
18 Mar 2015	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

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

Product as listed by the FDA

RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.

Where it was distributed

Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

All serial numbers.

Where was it sold?

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 70203

Reported	Class	Recall	Company	Reason	Where
18 Mar 2015	CLASS II	RAPIDLab 1265 System recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Other	Nationwide
18 Mar 2015	CLASS II	RAPIDLab 1245 System recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Other	Nationwide
18 Mar 2015	CLASS II	RAPIDPoint 405 Blood Gas Analyzer recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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