FDA (Devices) recall action 81955
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.
When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination.
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.
Siemens is recalling 5,373 Dimension Vista 1500 analyzers because specific water purification modules may cause falsely elevated triglyceride results.
Siemens is recalling 5,373 Dimension Vista 500 analyzers because specific Millipore water purification modules may cause falsely elevated triglyceride results.