AutoCheck5 의 리콜

Recall

78097

Class 2

Z-3237-2017

2017-09-07

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158651

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).

Radiometer sent a Safety Notice dated September 7, 2017, to all affected customers. The firm initiated their recall on 09/07/2017 by email. The letter requested the following: 1. Please check your inventory and analyzers for any boxes and ampoules of above mentioned QC. 2. Discard all Boxes and ampoules of this lot. 3. Complete the response form and return it to the number on the form. Please note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-user. Customers with questions were advised to contact their Radiometer representative.