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Class 3 Device Recall GBS QC Set (Live Culture) |
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Date Initiated by Firm |
December 16, 2020 |
Create Date |
January 31, 2022 |
Recall Status1 |
Terminated 3 on January 12, 2023 |
Recall Number |
Z-0546-2022 |
Recall Event ID |
89384 |
510(K)Number |
K861022
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Product Classification |
Kit, quality control for culture media - Product Code JTR
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Product |
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U.
Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM) |
Code Information |
Main Product Codes: Catalog Number: 8164, Lot Number: 8164-78, UDI: 70845357028623, Expiration date: 09/30/2021.
Affected Component Codes: Catalog Number: 0243U, Lot Number: 243-48-5, UDI: 10845357004083, Expiration Date on Label: 07/31/2020, Correct Expiration Date: 07/31/2022. |
Recalling Firm/ Manufacturer |
Microbiologics Inc 200 Cooper Ave N Saint Cloud MN 56303-4440
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For Additional Information Contact |
Becky Neu 320-229-7073
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Manufacturer Reason for Recall |
The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
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FDA Determined Cause 2 |
Employee error |
Action |
Microbiologics notified customers on about 12/16/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to update records with the correct expiration date of 07/31/2022 and keep the letter for their records.
Questions or concerns can be directed to Recall Support team at
320.229.7073 or recall@microbiologics.com. |
Distribution |
US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JTR and Original Applicant = MICRO-BIO-LOGICS
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