FDA (Devices) recall action 97141
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.
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
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.
BD Trucount Controls 30 Test kits are being recalled because they contain incorrect standard deviation values for the low and high control beads, which compromises accurate bead count calculation. 629 kits affected.
BD Trucount Controls 30 Test kits, REF 664343, are being recalled because they contain incorrect standard deviation values for the low and high control beads. 10 kits are affected.