Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005.
FDA device recall Z-1387-06 · posted 2006-08-10 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Under certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
- Action taken
- The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual.
- Root cause
- Other
- Status
- Terminated
- Product code
- JFP
- Quantity affected
- 196 devices
- Distribution
- Nationwide.
- Date initiated
- 2005-09-29
- Date posted
- 2006-08-10
- Date terminated
- 2012-04-17
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |