Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.
FDA device recall Z-1386-06 · 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
- 1615 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 |
|---|---|---|
| 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 |
| ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130) | Radiometer America, Inc. | 1998-02-09 |