FDA (Devices) recall action 88323
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
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.
Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic accuracy.
Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.
Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.
Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.
Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.