D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
FDA device recall Z-1314-06 · posted 2006-08-01 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- The CI membrane units generate too low values for status and sensitivity during calibration.
- Action taken
- The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGZ
- Quantity affected
- 85/4 unit boxes
- Distribution
- Nationwide.
- Date initiated
- 2005-02-01
- Date posted
- 2006-08-01
- Date terminated
- 2011-11-18
- Location
- Westlake, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130) | Radiometer America, Inc. | 1998-02-09 |