Radiometer America Inc: Medical Device Recall in 2017 - (Recall #: Z-3237-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

Product Classification:

Class II

Date Initiated: September 7, 2017

Date Posted: October 11, 2017

Recall Number: Z-3237-2017

Event ID: 78097

Reason for Recall:

Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)

Status: Terminated

Product Quantity: 1669 Boxes

Code Information:

S7745 Lot R0698

Distribution Pattern:

Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.

Voluntary or Mandated:

Voluntary: Firm initiated