Recall Z-0697-2016 ยท LKP Anti-Sm Antibody, Antigen And Control
Phadia Ab
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
| Date | Jan 28, 2016 (initiated Dec 28, 2015) |
| Status | Terminated |
| 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. |
| 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 | 76 |
| Distribution | US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132631 | EIA SMDP IMMUNOASSAY Phadia US, Inc., Aug 29, 2014 |