Z-0304-2021Class II

Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an...

Name: Z-0304-2021 Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an...
Creator: Microbiologics Inc
Published: 2020-10-08
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2020-10-08 / Terminated

FDA source

Microbiologics Inc began a recall of Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a... on 2020-10-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0304-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-08
Posted: 2020-10-27
Terminated: 2022-11-17
Recalling firm: Microbiologics, Inc.
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.
Product code: JTR Kit, Quality Control For Culture Media
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.
FDA root cause: Under Investigation by firm
Action: The recalling firm is sending consignees recall notification letters beginning 10/08/2020 via email. The correction communication was first extended to the first level of the distribution change (those who received product directly from Microbiologics). Distributors outside of the US will be contacted via email, and if follow up is necessary, the recalling firm's international sales team will work with each distributor to ensure this communication is extended to their end users. The recalling firm is working with its European Authorized Representative to coordinate this field safety corrective action in the EU.
Quantity in commerce: 5 units
Distribution: Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
Product codes and lots: Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0304-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0302-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-27
Z-0303-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-27
Z-0304-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-27

Product code JTR

K861022Class IKwik Stik(tm) Lyfo(tm) Disk MicroorganismsMicro-Bio-Logics / cleared 1986-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)