| Date Initiated by Firm | June 17, 2025 |
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| Date Posted | July 17, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2124-2025 |
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| Recall Event ID |
97096 |
| 510(K)Number | K861022 |
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| Product Classification |
Kit, quality control for culture media - Product Code JTR
|
| Product | KWIK-STIK and LYFO DISK, quality control kit for culture media
Catalog # 0805K and 0805L |
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| Code Information |
Lot #: 805-234-4, 805-234-5
UDI: (0805K) 30845357019531, (0805L) 10845357019544 |
Recalling Firm/
Manufacturer |
Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
|
| For Additional Information Contact | Rebecca Neu
320-253-1640 |
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Manufacturer Reason
for Recall | Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On June 17. 2025, the firm began notifying affected customers via "Urgent Medical Device Recall" letters delivered through email.
Customers were instructed to review lab procedures to understand how the information may affect usage; use or discard product depending on lab procedures. Complete and return the response form to recall@microbiologics.com. If product was further distributed or transferred to other facilities or customers, they should also be notified.
Customers may contact Microbiologics if a replacement kit is needed.
If you have any questions or concerns, contact Recall Support team at 320.229.7080 or recall@microbiologics.com. Collect calls may be made. |
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| Quantity in Commerce | 21 total |
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| Distribution | US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh. |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JTR
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