| Class 2 Device Recall Microbiologics KWIKSTIK |  |
Date Initiated by Firm | March 06, 2024 |
Date Posted | April 05, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1483-2024 |
Recall Event ID |
94201 |
510(K)Number | K861022 |
Product Classification |
Kit, quality control for culture media - Product Code JTR
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Product | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media |
Code Information |
a) REF 0209P, UDI/DI 20845357003113, Lot Numbers: 209-37-1, 209-37-3, 209-37-4, 209-37-5;
b) REF 0209K, UDI/DI 30845357003127, Lot Numbers: 209-37-2 |
Recalling Firm/ Manufacturer |
Microbiologics Inc 200 Cooper Ave N Saint Cloud MN 56303-4440
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For Additional Information Contact | Rebecca Neu 320-229-7080 |
Manufacturer Reason for Recall | The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material. |
FDA Determined Cause 2 | Use error |
Action | Microbiologics issued an Urgent Medical Device Recall notice to its consignees on 03/06/2024 via email. The notice explained problem with the device and provided the following instructions:
2. USE OR DISCARD depending on your lab procedures and how this information affects your usage.
3. COMPLETE the response form provided.
4. RETURN the response form to recall@microbiologics.com
5. KEEP this letter for your records.
6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred.
7. CONTACT Microbiologics if a replacement kit is needed.
For questions contact Recall Support team at 320.229.7080 or recall@microbiologics.com |
Quantity in Commerce | 19 units |
Distribution | Worldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM, TN, PR, and the countries of France, Columbia, Kazakhstan, Peru, Puerto Rico, South Africa. |
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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