Reported May 17, 2017 · Terminated

RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory…

Siemens Healthcare Diagnostics Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637

Is this the product you have?

  • RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software 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
  • Siemens SMN numbers
    • 10492730
    • 10696857
    • 10697306
Lot codes and dates
  • Serial Numbers

    159 of 159 codes

    • 30762
    • 32470
    • 33999
    • 35395
    • 36284
    • 39672
    • 40405
    • 40456
    • 40508
    • 30779
    • 33198
    • 34000
    • 35462
    • 37243
    • 39688
    • 40406
    • 40460
    • 40509
    • 30784
    • 33201
    • 34082
    • 35688
    • 37261
    • 39689
    • 40407
    • 40461
    • 40510
    • 30819
    • 33232
    • 34083
    • 35690
    • 37275
    • 39690
    • 40408
    • 40464
    • 40512
    • 30841
    • 33370
    • 34291
    • 35692
    • 37292
    • 39691
    • 40409
    • 40466
    • 40561
    • 30842
    • 33438
    • 34427
    • 35693
    • 37295
    • 39692
    • 40410
    • 40467
    • 40562
    • 30844
    • 33459
    • 34438
    • 35703
    • 37296
    • 39693
Amount recalled
159 units

Where it was sold

  • Nationwide

Why it was recalled

Potential Patient Demographic Error with Blank Patient ID Field

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 20, 2019 · Data as of Sep 19, 6:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.