Recall Z-0304-2021— Microbiologics Inc
Class II · Terminated
Class II FDA medical device recall by Microbiologics Inc, initiated 2020-10-08, terminated 2022-11-17. It names one FDA 510(k) clearance: K861022. Product: 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 or 6.. Reason: QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-08
- Terminated
- 2022-11-17
- 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
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 or 6.
Reason for recall
QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
Data sourced from openFDA. This site is unofficial and independent of the FDA.