QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Cultur...
FDA Device Recall #Z-0589-2022 — Class II — February 18, 2020
Recall Summary
| Recall Number | Z-0589-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 18, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Microbiologics Inc |
| Location | Saint Cloud, MN |
| Product Type | Devices |
| Quantity | 3 units |
Product Description
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Reason for Recall
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
Distribution Pattern
Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Lot / Code Information
Catalog Number: 5229P; Lot Numbers (Expiration Date): 5229-01 (07/31/2020), 5229-02 (09/30/2020), 5229-03 (09/30/2020); UDI: 70845357038899
Other Recalls from Microbiologics Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0986-2026 | Class II | LYFO DISK, Campylobacter jejuni subsp. jejuni d... | Dec 2, 2025 |
| Z-0984-2026 | Class II | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. j... | Dec 2, 2025 |
| Z-0985-2026 | Class II | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. j... | Dec 2, 2025 |
| Z-0876-2026 | Class II | KWIK-STIK, Quality control kit for culture medi... | Nov 13, 2025 |
| Z-2194-2025 | Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, pa... | Jun 27, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.