Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode
FDA device recall Z-1323-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
- Action taken
- Following the receipt of three (3) customer complaints, on 9/14/2005, the firm issued an E-Mail notification [Management Cover] to their Service Personnel on 9/19/2005. The Management Cover instructed the service personnel to check the electrodes located at their stock and their customer locations; put all electrodes, which cannot be inserted in their call-back stock; and provide for credit to their customers through normal channels. The Service Personnel in turn, contacted their customers via telephone on or around 9/20/2005 and asked that they check their inventories for the presence of any electrodes which would not fit in the analyzer and return any such electrodes to Radiometer America for replacement
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 34
- Distribution
- Nationwide and Canada.
- Date initiated
- 2005-09-19
- Date posted
- 2006-08-03
- Date terminated
- 2012-02-24
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130) | Radiometer America, Inc. | 1998-02-09 |