| Date Initiated by Firm | December 01, 2021 |
|---|
| Create Date | February 02, 2022 |
|---|
| Recall Status1 |
Terminated 3 on January 09, 2023 |
| Recall Number | Z-0554-2022 |
|---|
| Recall Event ID |
89151 |
| 510(K)Number | K960996 |
|---|
| Product Classification |
Discs, strips and reagents, microorganism differentiation - Product Code JTO
|
| Product | HARDY DIAGNOSTICS CatScreen, 25dsk/vial |
|---|
| Code Information |
Model Number HADZ110, all lots |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
866-359-1704 |
|---|
Manufacturer Reason
for Recall | Product stored incorrectly in temperature controlled setting instead of refrigeration. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed. |
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| Quantity in Commerce | 100 units (4 packs, 25 per pack) |
|---|
| Distribution | US Nationwide distribution in the state of California. |
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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 = JTO
|
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