Food, drugs, devices › Phadia Ab
Device recall: EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measur
Phadia Ab (Uppsala, N/A) initiated this device recall on 28 Dec 2015; FDA lists 1 product record under event 72969, classified Class II.
FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 16 Aug 2016. Initiation: voluntary: firm initiated. Phadia Ab has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Phadia Ab, Uppsala, N/A, Sweden.
Reason for recall
"All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies."
Distribution
"US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0697-2016 | 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… | 76 | Class II | Terminated | 3 Feb 2016 |
Context
Other enforcement events for Phadia Ab
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 May 2023 | EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic | Device | Class II | 1 |
| 9 Jul 2019 | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including sof | Device | Class II | 1 |
| 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 | Device | Class II | 1 |
| 20 Nov 2017 | Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.