Phadia Ab Recalls

Overview of recall records associated with Phadia Ab, including dates, categories and classifications where available.

4recall records

Jan 31, 2024latest record date

Apr 11, 2018earliest record date

Recall history in this database

Classification mix: Class II: 4.

Medical DeviceJan 31, 2024

Phadia Ab EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000 recall — FDA Z-0783-2024

Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells…

Class IIFDA: OngoingPhadia Ab

Medical DeviceSep 4, 2019

Phadia Ab Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated recall — FDA Z-2397-2019

code 7-102 Liquid Sensor Error

Class IIFDA: TerminatedPhadia Ab

Medical DeviceJul 10, 2019

Phadia Ab EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for recall — FDA Z-1907-2019

Potential for reporting low assay results

Class IIFDA: TerminatedPhadia Ab

Medical DeviceApr 11, 2018

Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 recall — FDA Z-1276-2018

We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and…

Class IIFDA: TerminatedPhadia Ab

Understanding this recall history

This page summarizes recall records in which the official source identifies Phadia Ab as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.