FDA Device recall 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 antibo…
- FDA Device
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibo… by Phadia Ab, citing 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 investig….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0697-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-28 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Phadia Ab |
| Distribution | US |
Product
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 clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
Reason
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.
Identifiers
| code_info | Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2016%22
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