The Recall Desk

FDA (Devices) recall action 62503

Radiometer America Inc recalled 3 products on 2012-08-15

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2012-08-15
Critical
0
Units
—

Why these products were recalled

A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2012-08-15

    Radiometer ABL90 FLEX Software Recall for HL7 Data Transmission Errors

    Radiometer America Inc. is recalling ABL90 FLEX software version 2.7 MR3 because a data transfer error can cause mixed-up results when transmitting to hospital systems.

    Product
    ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
    Category
    Distribution
    50 states
  • ModerateFDA (Devices)··2012-08-15

    Radiometer ABL Software Recall for HL7 Data Transmission Errors

    Radiometer America Inc. is recalling ABL software version 6.12 for ABL800 and ABL700 analyzers because HL7 2.5 data transmission errors can mix up queued results.

    Product
    The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the
    Category
    Distribution
    50 states
  • ModerateFDA (Devices)··2012-08-15

    Radiometer ABL800 Software Recall for HL7 Data Transmission Errors

    Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.

    Product
    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin f
    Category
    Distribution
    50 states