Phadia Ab: FDA recalls

FDA enforcement reports name Phadia Ab as the recalling firm in 5 events. The events have 5 product records. The recalls started from 2015 to 2023. All the events are device recalls.

See the 5 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

5 events, newest first.

FDA enforcement events of Phadia Ab
Initiated	Product (first record)	Type	Class	Records	Status
24 May 2023	EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic	Device	Class II	1	Ongoing
9 Jul 2019	Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.	Device	Class II	1	Terminated
10 May 2019	EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings.…	Device	Class II	1	Terminated
20 Nov 2017	Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.	Device	Class II	1	Terminated
28 Dec 2015	EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Phadia Ab: events for each product type
Type		Events
Device		5

Phadia Ab: events in each class
Class		Events
Class II		5

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Phadia Ab, by the year that the recall started. The largest year is 2019, with 2 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Phadia Ab: FDA recalls. https://recallregister.com/firm/phadia-ab/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Phadia Ab have?: Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Phadia Ab?: FDA event 93403, which the firm started on 24 May 2023. The first product in the record is: EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
How many FDA recalls of Phadia Ab have the status Ongoing?: 1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.