FDA (Devices) recall action 79292
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
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.
Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing inaccurate prothrombin time test results.
Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a defect may cause inaccurate prothrombin time test results.
Diagnostica Stago is recalling STA Neoplastine Cl Plus reagent vials due to a confirmed homogeneity defect that may cause inaccurate prothrombin time test results.
Diagnostica Stago, Inc. is recalling STA Neoplastine Cl reagent vials because a homogeneity defect may cause inaccurate prothrombin time test results.