Radiometer D788 pCO2 Membranes Recalled for Biased Measurement Results
Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that provides inaccurate diagnostic data (biased measurement results), which poses a risk of harm to patients through potential misdiagnosis or treatment errors, fitting the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.
Plain-English summary
Radiometer America, Inc. is recalling D788 pCO2 membranes distributed in the United States and internationally. The recall involves 38,890 units, of which 7,860 were imported into the US. The affected products are identified by Model # 942-063 and Lot #s R338 to R493.
The recall was initiated because Radiometer became aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as quality control (QC) results. These membranes are used in automatic or semi-automatic instruments that identify and quantify gases and electrolytes in whole blood.
The products were distributed nationwide in the US, including DC and all states, as well as in Bermuda and Canada. Consumers and healthcare facilities should stop using the affected membranes and contact Radiometer America for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Radiometer America Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model #: 942-063 Lot #'s: R338 to R493
Distribution
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