QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Num...

FDA Device Recall #Z-0587-2022 — Class II — February 18, 2020

Recall Summary

Recall Number Z-0587-2022
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 10 units

Product Description

QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. 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: 5112P; Lot Numbers: 5112-01 (Expiration Date 07/31/2020), 5112-02 (Expiration Date 10/31/2020); UDI: 70845357026551

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.