Recall Z-1011-2011 ยท CEM Electrode, Ion Specific, Potassium
Radiometer America Inc
ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.
| Date | Feb 2, 2011 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result. |
| Root cause | Software design |
| Action | On 11/16/10 the firm sent Medical Device Field Correction letters to their customers. The letter states that all systems will be upgraded and until each system is upgraded, they instructed their customer to "always query for patient ID prior to introducing the sample." They also instruct each customer to complete the "Fax Return Form" acknowledging receipt of the letter. If customers have questions regarding the letter or the upgrade, they should contact Technical Support at 1-800-736-0600 Opt 4. |
| Quantity | 432 units |
| Distribution | Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092686 | ABL90 FLEX SERIES Radiometer Medical Aps, Aug 6, 2010 |