pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument us
FDA device recall Z-1075-2014 · posted 2014-02-24 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
- Action taken
- On 7/18/2013, the firm sent Product Notification letters to their customers.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 38,890 units (7,860 units imported into the US)
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, N
- Date initiated
- 2013-07-05
- Date posted
- 2014-02-24
- Date terminated
- 2015-09-19
- 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 |
|---|---|---|
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |
| ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130) | Radiometer America, Inc. | 1998-02-09 |