| Date Initiated by Firm | February 08, 2017 |
|---|
| Date Posted | May 15, 2017 |
|---|
| Recall Status1 |
Terminated 3 on February 08, 2019 |
| Recall Number | Z-2168-2017 |
|---|
| Recall Event ID |
76659 |
| 510(K)Number | K981521 |
|---|
| Product Classification |
System, test, thyroid autoantibody - Product Code JZO
|
| Product | AIA-PACK TPOAb CONTROL SET |
|---|
| Code Information |
TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017 |
Recalling Firm/
Manufacturer |
Tosoh Bioscience, Inc.
6000 Shoreline Ct Ste 101
South San Francisco CA 94080-7606
|
| For Additional Information Contact | Mrs. Susan H. Koss
614-317-1909 |
|---|
Manufacturer Reason
for Recall | The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label. |
|---|
FDA Determined
Cause 2 | Labeling mix-ups |
|---|
| Action | On 3/3/2017 the firm sent recall notificaion letters to their customers. |
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| Quantity in Commerce | 15 boxes |
|---|
| Distribution | Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX. |
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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 = JZO
|
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