The company will need to revalidate the entire assembly process of the Triage product. The recall was made back in July of this year. The Triage product helps diagnose health conditions such as heart attacks and heart failure, pretty important. The FDA feels there are too many potential incidents of False Positive or False Negative results. There were reports of patients receiving inappropriate management based on the readings the machines were giving and it could jeopardize patient safety and even lead to death. Additional recall information can be found here. BD
FDA Class One Recall for Triage Diagnostics Tests (Multiple)–Potential For Increased Frequency of False Positive or False Negative Results
(Reuters) - The Food and Drug Administration issued a warning letter to Alere Inc saying the diagnostic device maker's response to the health regulator's earlier observations on manufacturing processes for the company's Triage products was not adequate.
The FDA said in its letter on Monday that Alere will need to complete a revalidation of the entire assembly process of adding, dispensing and packaging the Triage products at its San Diego, California facility.
The company recalled 104 lots of its Triage cardiology products from the facility in May after the FDA said it did not satisfy a particular quality control method as prescribed by the regulator.
"While the FDA warning letter is not material news by itself, Alere's level of transparency and execution has been frustrating," Goldman Sachs analyst Isaac Ro said in a note to clients.