Device recall: Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since…
Class II FDA enforcement event 69872. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Phadia US Inc started this device recall on 20 Nov 2014. The firm address in the FDA record is in Portage, MI. FDA put the recall in Class II. FDA event 69872 has 1 product record. The first FDA enforcement report date is 21 Jan 2015. The record gives the status Terminated, with the termination date 30 Jun 2015.
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.
Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
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-0947-2015 | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for… | 146 | Class II | Terminated | 21 Jan 2015 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- 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 |
| 2 Aug 2012 | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) | Device | Class III | 1 |
Official channels
- FDA enforcement report Z-0947-2015The 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.
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Cite this page
Recall Register. FDA enforcement event 69872. https://recallregister.com/fda/ii/69872/. 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:
Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
- What quantity of product is in FDA event 69872?
- The FDA record gives this quantity:
146
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.