Microbiologics Inc KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog Number HL163263 OEM Private Label with Healthlink, 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015)
Products Sold
Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 before UDI was required for class 1 IVDs) Lot Number (Expiration Date): 959-74-1 (10/08/2014), 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015)
Microbiologics Inc is recalling KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus due to This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamici. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
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