Device recall: PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Class III FDA enforcement event 62572. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Phadia US Inc started this device recall on 2 Aug 2012. The firm address in the FDA record is in Portage, MI. FDA put the recall in Class III. FDA event 62572 has 1 product record. The first FDA enforcement report date is 5 Sep 2012. The record gives the status Terminated, with the termination date 12 Dec 2012.
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 . openFDA export of .
Distribution
In the words of FDA.
USA Nationwide.
Recalling firm
Phadia US Inc, Portage, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2285-2012 | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) | 837 kits (96 assays per kit), total of 80,352 individual assays | Class III | Terminated | 5 Sep 2012 |
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.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class III
- 6%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 May 2023 | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for th | Device | Class II | 2 |
| 14 Dec 2020 | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA | Device | Class II | 1 |
| 18 Dec 2017 | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay | Device | Class II | 2 |
| 5 Jul 2017 | Phadia 1000 Instrument, Article Number 12-3800-01. | Device | Class II | 1 |
| 30 Jan 2017 | EliA Sample Diluent, Article number, 83-1023-01 | Device | Class II | 1 |
| 20 Nov 2014 | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since l | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2285-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 62572. https://recallregister.com/fda/iii/62572/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
USA Nationwide.
- What quantity of product is in FDA event 62572?
- The FDA record gives this quantity:
837 kits (96 assays per kit), total of 80,352 individual assays
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 6% of the 823 device events that started in 2012 are in Class III.