ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therap
FDA device recall Z-1011-2011 · posted 2011-02-02 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 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, No
- Date initiated
- 2010-11-01
- Date posted
- 2011-02-02
- Date terminated
- 2012-05-09
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL90 FLEX SERIES (K092686) | Radiometer Medical Aps | 2010-08-06 |