FDA (Devices) recall action 98004
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.
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
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.
Cepheid is recalling 6,325 Xpert BCR-ABL Ultra kits, catalog GXBCRABL-US-10, because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.
Cepheid is recalling 4,032 Xpert BCR-ABL Ultra test kits because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.