Recall Z-1075-2014— Radiometer America Inc
Class II · Terminated
Class II FDA medical device recall by Radiometer America Inc, initiated 2013-07-05, terminated 2015-09-19. It names 2 FDA 510(k) clearances: K041874, K980130. Product: pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.. Reason: RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results..
- Recalling firm
- Radiometer America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-05
- Terminated
- 2015-09-19
- Firm location
- Westlake, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K041874 — ABL800 FLEX
- K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.