ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
FDA device recall Z-1325-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
- Action taken
- The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 36
- Distribution
- Worldwide, including USA and Canada.
- Date initiated
- 2005-10-31
- Date posted
- 2006-08-03
- Date terminated
- 2012-02-24
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |