| Date Initiated by Firm | October 21, 2016 |
|---|
| Date Posted | August 23, 2018 |
|---|
| Recall Status1 |
Terminated 3 on November 05, 2019 |
| Recall Number | Z-2919-2018 |
|---|
| Recall Event ID |
80684 |
| 510(K)Number | K905194 |
|---|
| Product Classification |
Anti-rnp antibody, antigen and control - Product Code LKO
|
| Product | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sjgren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process. |
|---|
| Code Information |
Lot #'s: TS2725 (kit) and TS 2733 (PC) |
Recalling Firm/
Manufacturer |
Euro Diagnostica AB
Box 50117
Lundavagen 151
Malmo Sweden
|
Manufacturer Reason
for Recall | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
|---|
FDA Determined
Cause 2 | Error in labeling |
|---|
| Action | none |
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| Quantity in Commerce | 4 |
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| Distribution | MN |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LKO
|
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