FDA (Devices) recall action 90266
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.
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
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.
Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.
Chromsystems has recalled MassCheck Amino Acid, Acylcarnitines dried blood controls (batch 2821) for insufficient glycine concentration. This may affect laboratory test accuracy.