| Date Initiated by Firm | July 05, 2017 |
|---|
| Create Date | January 18, 2018 |
|---|
| Recall Status1 |
Terminated 3 on October 04, 2018 |
| Recall Number | Z-0387-2018 |
|---|
| Recall Event ID |
78752 |
| 510(K)Number | K133404 K161899 |
|---|
| Product Classification |
System, test, radioallergosorbent (rast) immunological - Product Code DHB
|
| Product | Phadia 1000 Instrument, Article Number 12-3800-01. |
|---|
| Code Information |
All versions of the instrument |
Recalling Firm/
Manufacturer |
Phadia US Inc
4169 Commercial Ave
Portage MI 49002-9701
|
| For Additional Information Contact |
269-833-1819 |
|---|
Manufacturer Reason
for Recall | The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon. |
|---|
| Quantity in Commerce | 70 units |
|---|
| Distribution | Nationwide |
|---|
| 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 = DHB
|
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