| Date Initiated by Firm | March 18, 2021 |
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| Create Date | January 18, 2022 |
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| Recall Status1 |
Terminated 3 on August 28, 2023 |
| Recall Number | Z-0504-2022 |
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| Recall Event ID |
89337 |
| Product Classification |
Culture media, non-propagating transport - Product Code JSM
|
| Product | Gentueri Viral Transport Medium (VTM), Sterile, IVD |
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| Code Information |
CAT #: 3300-000; Lot #: 1142 |
Recalling Firm/
Manufacturer |
Gentueri Inc
312 Locust Dr
Verona WI 53593-2215
|
| For Additional Information Contact | Randy Nagy
608-949-8568 |
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Manufacturer Reason
for Recall | Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing. |
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FDA Determined
Cause 2 | Environmental control |
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| Action | The firm called the customer on 03/19/2021 and indicated that there was a possible contamination of Lot 1142 and that this needed to be held at distribution facilities.
Following the conversation, Gentueri emailed as an attachment a "Removal Notification," for VTM Lot 1142 that explained that the lot failed to pass inspection and all product from this lot at the customer's site needed to be returned. Customers with any questions are to contact Gordon S. Hunter, Marketing Manager for Gentueri, at ghunter@gentueri.com or 1-608-497-0366. |
|---|
| Quantity in Commerce | 4,150 units |
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| Distribution | US Nationwide distribution in the state of Indiana. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
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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.
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