Reported Feb 3, 2016 · Terminated
EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative…
Phadia Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Phadia Ab · Rapsgatan 7 · Uppsala, N/A · N/A
Is this the product you have?
- EliA SmDP Well
- Article Number 14-5624-01 Product UsageEliA 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
- Lot codes and dates
- Product number14-5624-01
- Lot0018
- Exp date11/30/2016
- Amount recalled
- 76
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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