KWIK-STIK AST-GP QC Set (Microbiologics) – Incorrect Test Results (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog Number: 5112P, Lot Numbers: 5112-01 (Expiration Date 07/31/2020), 5112-02 (Expiration Date 10/31/2020), UDI: 70845357026551
Products Sold
Catalog Number: 5112P; Lot Numbers: 5112-01 (Expiration Date 07/31/2020), 5112-02 (Expiration Date 10/31/2020); UDI: 70845357026551
Microbiologics Inc is recalling QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number due to Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Microbiologics notified customers on about 02/18/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions included the following: 1. REVIEW lab procedures to understand how thisinformation affects your usage; 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. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Technical Support team at 320.229.7045 or recall@microbiologics.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026