Microbiologics Inc: Medical Device Recall in 2020 - (Recall #: Z-0304-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 8, 2020

Date Posted: November 4, 2020

Recall Number: Z-0304-2021

Event ID: 86576

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.

Status: Terminated

Product Quantity: 5 units

Code Information:

Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335

Distribution Pattern:

Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated