Z-3237-2017 Class II Terminated
FDA device recall Z-3237-2017 was initiated by Radiometer America Inc on September 7, 2017 and is designated Class II. 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 … The recall status is terminated (terminated August 1, 2019). Affected quantity: 1669 Boxes.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2017
- Initiation Date
- September 7, 2017
- Termination Date
- August 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1669 Boxes
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
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)
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.
Code Information
S7745 Lot R0698