FDA (Devices) recall action 82017
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.
Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
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.
Carolina Liquid Chemistries is recalling 14 Etha RGT. Kits (Lot 11686) due to quality concerns. The recall is voluntary and has been terminated.
Carolina Liquid Chemistries is recalling 20 Ethyl Alcohol Assay Kits because supplier testing showed the absorbance rate did not meet internal quality control specifications.