FDA (Devices) recall action 79374
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 concentration of bromocresol purple in the recalled lots does not conform to specification.
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.
Mesa Laboratories is recalling SporAmpule Biological Indicators because the concentration of bromocresol purple does not conform to specification.
Mesa Laboratories is recalling specific lots of ProSpore Biological Indicators because the concentration of bromocresol purple does not conform to specification.