Recall Z-0584-2022— Microbiologics Inc
Class II · Terminated
Class II FDA medical device recall by Microbiologics Inc, initiated 2020-10-01, terminated 2022-07-07. It names one FDA 510(k) clearance: K861022. Product: QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.. Reason: Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-01
- Terminated
- 2022-07-07
- 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
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.
Reason for recall
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Data sourced from openFDA. This site is unofficial and independent of the FDA.