MEDICAL ALERT Food & Drug Administration
1. Maquet Datascope Corp./Getinge Group Recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) Due to Possible Malfunction and Failure at High Altitudes
2. The FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication
3. Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results
Maquet Datascope Corp./Getinge Group Recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) Due to Possible Malfunction and Failure at High Altitudes
Reason for Recall-Maquet Datascope Corp. is recalling the Cardiosave Hybrid and Cardiosave Rescue IABPs due to the potential of the autofill process to malfunction or fail during use at altitudes above 3200 feet. This failure may result in either interruption or cessation of therapy upon the first maintenance autofill or the inability to start therapy.
See FDA for Full Details,
The FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication
The FDA has become aware of genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as, depression, heart conditions, acid reflux, and others.
Do not change or stop taking any medicine based on a report from a genetic test you took on your own. Discuss the results of the genetic test with your health care provider, including whether the medication label includes information on how to use genetic information to determine dosage, and whether your health care provider recommends changes to your treatment. Medicine should always be taken as prescribed by your health care provider.
Be aware that most genetic tests that make claims about the effects of a specific medicine are not supported by enough scientific information or clinical evidence.
See FDA for Full Details,
Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results
Reason for Recall
Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT Test Strips in January 2018 to correspond to a newly released INR International Standard. Since this re-calibration, Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with the affected CoaguChek XS PT Test Strips.
Use of affected products may increase the risk of serious adverse health consequences, including death.
For Full Details and Recall Product Information see FDA website,
Disclaimer-De Faakto Intelligence Research is provided to first responders for situational awareness, advice, guidance and educational purposes. Intelligence is perishable and fluid. Intelligence is updated and reassessed as new information becomes available. Sources are evidence based and multiple sources are used when possible. Sometimes intelligence assessments present gaps in information, this is a reality in intelligence led operations and gaps are filled when information presents. Emergency first responders should always follow best industry practices, organizational policy-procedures and regulatory standards.