​Abbott—ARCHITECT ICT Modules: Serum or Plasma Chloride Results May Be Higher than Expected

September 12, 2018 | Strategic Insights for Health System


​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In an August 28, 2018, Product Recall Urgent Immediate Action Required letter submitted by an ECRI Institute member hospital, Abbott states that it has received reports of higher-than-expected serum or plasma chloride results when the above modules are used. Abbott also states that based on an analysis of quality control (QC) data from customers, the results generated using the above lot number may be up to 6.2% higher than expected. The customer QC data does not indicate a problem with urine chloride results. Abbott further states that since this problem affects only the chloride element of the ICT module, potassium and sodium results are not affected; however, reporting of chloride ICT results may be delayed because of the time required for the user to troubleshoot the problem with falsely elevated serum chloride QC results. The manufacturer has not confirmed the...

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