| Date Initiated by Firm | October 21, 2016 |
|---|
| Date Posted | August 23, 2018 |
|---|
| Recall Status1 |
Terminated 3 on November 05, 2019 |
| Recall Number | Z-2922-2018 |
|---|
| Recall Event ID |
80684 |
| 510(K)Number | K912291 |
|---|
| Product Classification |
Antinuclear antibody, antigen, control - Product Code LKJ
|
| Product | is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process. |
|---|
| Code Information |
Lot #'s: TS 1740 (kit) and TS 1743 (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 = LKJ
|
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