The Recall Desk

FDA (Devices) recall action 72044

Siemens Healthcare Diagnostics Inc recalled 4 products on 2015-09-30

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2015-09-30
Critical
0
Units
4,323

Why these products were recalled

RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: 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…
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    Distribution
    0 states
  • HighFDA (Devices)··2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 1,213 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 49 RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 982 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: 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…
    Category
    Distribution
    0 states