Recall Z-0712-2022— Microbiologics Inc
Class II · Terminated
Class II FDA medical device recall by Microbiologics Inc, initiated 2014-10-06, terminated 2023-01-17. It names one FDA 510(k) clearance: K861022. Product: KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299. Reason: 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..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-06
- Terminated
- 2023-01-17
- Firm location
- Saint Cloud, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.