Phadia Ab: Medical Device Recall in 2016 - (Recall #: Z-0697-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 28, 2015

Date Posted: February 3, 2016

Recall Number: Z-0697-2016

Event ID: 72969

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.

Status: Terminated

Product Quantity: 76

Code Information:

Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016

Distribution Pattern:

US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.

Voluntary or Mandated:

Voluntary: Firm initiated