The Recall Desk

FDA (Devices) recall action 82104

Abbott Laboratories, Inc recalled 3 products on 2019-04-17

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2019-04-17
Critical
0
Units
9,135

Why these products were recalled

There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.

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

1–3 of 3

  • HighFDA (Devices)··2019-04-17

    Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potenti
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-04-17

    Abbott ARCHITECT c4000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-04-17

    Abbott ARCHITECT c8000 Processing Module Recall for Potential Incorrect Results

    Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Distribution
    1 state