|
Class 2 Device Recall KWIKSTIK |
|
Date Initiated by Firm |
October 08, 2020 |
Create Date |
October 27, 2020 |
Recall Status1 |
Terminated 3 on November 17, 2022 |
Recall Number |
Z-0302-2021 |
Recall Event ID |
86576 |
510(K)Number |
K861022
|
Product Classification |
Kit, quality control for culture media - Product Code JTR
|
Product |
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
|
Code Information |
Catalog 01145P, Lots 1145-06-1, 1145-06-2, 1145-06-3, 1145-06-4, 1145-06-6, 1145-07-1 UDI: UDI: 20845357036807 |
Recalling Firm/ Manufacturer |
Microbiologics Inc 200 Cooper Ave N Saint Cloud MN 56303-4440
|
For Additional Information Contact |
Emily Dunaisky 320-253-1640
|
Manufacturer Reason for Recall |
KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The recalling firm is sending consignees recall notification letters beginning 10/08/2020 via email. The correction communication was first extended to the first level of the distribution change (those who received product directly from Microbiologics). Distributors outside of the US will be contacted via email, and if follow up is necessary, the recalling firm's international sales team will work with each distributor to ensure this communication is extended to their end users. The recalling firm is working with its European Authorized Representative to coordinate this field safety corrective action in the EU. |
Quantity in Commerce |
30 units |
Distribution |
Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JTR and Original Applicant = MICRO-BIO-LOGICS
|
|
|
|