| Date Initiated by Firm | May 06, 2022 |
|---|
| Create Date | May 23, 2022 |
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| Recall Status1 |
Terminated 3 on January 16, 2024 |
| Recall Number | Z-1125-2022 |
|---|
| Recall Event ID |
90150 |
| 510(K)Number | K861022 |
|---|
| Product Classification |
Kit, quality control for culture media - Product Code JTR
|
| Product | KWIK-STIK" plus: Clostridium perfringens |
|---|
| Code Information |
catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374 |
Recalling Firm/
Manufacturer |
Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
|
| For Additional Information Contact | Becky Neu
320-229-7073 |
|---|
Manufacturer Reason
for Recall | Labeling error. |
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FDA Determined
Cause 2 | Labeling mix-ups |
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| Action | The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form. |
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| Quantity in Commerce | 8 units |
|---|
| Distribution | Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom. |
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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 = JTR
|
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