Recall Z-0697-2016— Phadia Ab

Name: FDA recall Z-0697-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-28

Class II · Terminated

Class II FDA medical device recall by Phadia Ab, initiated 2015-12-28, terminated 2016-08-16. It names one FDA 510(k) clearance: K132631. 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..

Recalling firm: Phadia Ab
Classification: Class II
Status: Terminated
Initiated: 2015-12-28
Terminated: 2016-08-16
Firm location: Uppsala, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K132631 — EIA SMDP IMMUNOASSAYPhadia US, Inc.·cleared 2014-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.