KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for cultur
FDA device recall Z-1483-2024 · posted 2024-04-05 · Open, Classified
Recall details
- Recalling firm
- Microbiologics Inc
- 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.
- Action taken
- 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
- Root cause
- Use error
- Status
- Open, Classified
- Product code
- JTR
- Quantity affected
- 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.
- Date initiated
- 2024-03-06
- Date posted
- 2024-04-05
- Location
- Saint Cloud, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |