The Recall Desk

FDA (Devices) recall action 84577

Beckman Coulter Inc. recalled 2 products on 2020-02-05

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
2020-02-05
Critical
0
Units
10,915

Why these products were recalled

Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

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.

1–2 of 2

  • HighFDA (Devices)··2020-02-05

    Beckman Coulter Recalls iChemVELOCITY Urine Chemistry Systems Due to Data Errors

    Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because they may report duplicate specimen IDs with conflicting patient data and results.

    Product
    iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-02-05

    Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.

    Product
    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis…
    Category
    Distribution
    0 states