FDA (Devices) recall action 84497
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Mindray is recalling six ABS800 Chemistry Analyzers due to a potential gas spring failure that poses a low risk of impact injury to users.
Mindray is recalling seven BA-800M Chemistry Analyzers because a gas spring on the protective cover may fail, posing a low risk of impact injury to users.