Recall Z-3237-2017 ยท JJS Controls For Blood-Gases, (Assayed And Unassayed)
Radiometer America Inc
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
| Date | Sep 7, 2017 |
| Status | Terminated |
| Reason | 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) |
| Root cause | Under Investigation by firm |
| Action | 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 Radio |
| Quantity | 1669 Boxes |
| Distribution | 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 F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 Radiometer America, Inc., Jan 28, 1998 |