Z-0697-2016Class II

EliA SmDP Well, Article Number 14-5624-01

Name: Z-0697-2016 EliA SmDP Well, Article Number 14-5624-01
Creator: Phadia Ab
Published: 2015-12-28
License: https://open.fda.gov/license/

Phadia AB / initiated 2015-12-28 / Terminated / root cause: manufacturing process

FDA source

Phadia Ab began a 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 antibodies directed to Sm... on 2015-12-28. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0697-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-28
Posted: 2016-01-28
Terminated: 2016-08-16
Recalling firm: Phadia AB
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.
Product code: LKP Anti-Sm Antibody, Antigen And Control
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 12/28/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions call 1-800-3464364, option #2.
Quantity in commerce: 76
Distribution: US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
Product codes and lots: Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0697-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0697-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-03	2016-01-27

Product code LKP

K132631Class IIEia Smdp ImmunoassayPhadia US, Inc. / cleared 2014-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)