ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer Syst
FDA device recall Z-2304-2012 · posted 2012-08-30 · Terminated
Recall details
- Recalling firm
- Sendx Medical Inc
- Reason for recall
- The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
- Action taken
- Radiometer sent a Field Safety Notice letter dated June 06, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. Also included is a Note to Users to be placed at the front of customers existing Operator's Manual. Customers were instructed to provide confirmation to Radiometer that all customers have received the letter and the Note to Users. For questions contact your Radiometer representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- ABL80 FLEX is 1680, ABL80 CO-OX is 1759
- Distribution
- Worldwide Distribution - US Nationwide including the state of OH.
- Date initiated
- 2012-06-06
- Date posted
- 2012-08-30
- Date terminated
- 2012-09-04
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL 80 CO-OX SYSTEM (K080370) | Sendx Medical, Inc. | 2008-07-31 |
| ABL80 FLEX ANALYZER (K051804) | Sendx Medical, Inc. | 2005-11-01 |