Z-0304-2021 Class II Terminated
FDA device recall Z-0304-2021 was initiated by Microbiologics Inc on October 8, 2020 and is designated Class II. 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. The recall status is terminated (terminated November 17, 2022). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- October 8, 2020
- Termination Date
- November 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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.
Distribution Pattern
Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
Code Information
Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335