The Recall Desk

FDA (Devices) recall action 67527

Abbott Laboratories recalled 2 products on 2014-06-04

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.

Products
2
Announced
2014-06-04
Critical
0
Units
7,780

Why these products were recalled

Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift

    Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.

    Product
    ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminesc
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift

    Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.

    Product
    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium
    Category
    Distribution
    3 states