Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
FDA device recall Z-1317-06 · posted 2006-08-02 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
- Action taken
- The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 1635 devices
- Distribution
- Nationwide.
- Date initiated
- 2005-06-17
- Date posted
- 2006-08-02
- Date terminated
- 2012-02-24
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290) | Radiometer Medical A/S | 2000-09-13 |
| ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (K992859) | Radiometer America, Inc. | 2000-01-10 |
| ABL 735 ANALYZER (K991417) | Radiometer America, Inc. | 1999-11-24 |