Z-0636-2022Class III

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized...

Name: Z-0636-2022 KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized...
Creator: Microbiologics Inc
Published: 2017-03-02
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2017-03-02 / Terminated / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir... on 2017-03-02. FDA classified it as Class III and gives the reason as "Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0636-2022
Classification: Class III
Status: Terminated
Initiated: 2017-03-02
Posted: 2022-02-10
Terminated: 2022-04-22
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Microbiologics notified customers on about 03/02/2017, via letter titled "Medical Device Recall." Customers were instructed to: 1. DO NOT USE any lot number 939-47-1 or 939-47-2 you may have in inventory. 2. QUARANTINE or DISCARD the product to prevent further use. 3. RETURN any remaining inventory you have of this product to Microbiologics via FED-EX though the use of FED-EX account number 355830926, and mark box Attention: Technical Manager. 4. Acknowledge your receipt of this information by completing the attached form and returning to Microbiologics by e-mailing to [email protected] or by faxing to 320.253.6250.
Quantity in commerce: 2 units
Distribution: International distribution in the countries of Canada and Germany.
Product codes and lots: Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0636-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0636-2022	Class III	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-10
Z-0637-2022	Class III	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)