| Date Initiated by Firm | October 19, 2026 |
|---|
| Date Posted | November 03, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0355-2027 |
|---|
| Recall Event ID |
100139 |
| 510(K)Number | K090968 |
|---|
| Product Classification |
Susceptibility test plate, antifungal - Product Code NGZ
|
| Product | Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens |
|---|
| Code Information |
YY3462 lot 440400
UDI-DI 848838018817 |
| FEI Number |
1924669
|
Recalling Firm/
Manufacturer |
Remel, Inc
12076 Santa Fe Trail Dr
Lenexa
KS
66215-3519
|
| For Additional Information Contact | Erica Knox
800-255-6730 |
|---|
Manufacturer Reason
for Recall | Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family. |
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FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | The firm began notifying affected customers on October 19, 2026.
Customers were instructed to notify any personnel who needed to be aware of the issue.
Customers should review previously reported susceptibility results generated using the affected lot and assess whether retesting is appropriate.
Customers should destroy any remaining inventory of the affected lot. Do not use it for any clinical laboratory testing.
Customers should complete and return the acknowledgement form accompanying the letter. Firm will replace product or issue credit.
If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
You should complete the accompanying Acknowledgment Form upon receipt and return to MBD.vigilance@thermofisher.com
|
|---|
| Quantity in Commerce | 33 US, 54 OUS |
|---|
| Distribution | Worldwide - US Nationwide distribution in the states of MA and CA. The countries of India, Saudi Arabia, UK. |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = NGZ
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