Recall Z-1483-2024 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
| Date | Apr 5, 2024 (initiated Mar 6, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 co |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS Micro-Bio-Logics, Apr 4, 1986 |