# K861022: Kwik Stik (TM) Lyfo (TM) Disk Microorganisms

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Bio-Logics
- Decided: Apr 4, 1986 after 17 days
- Product code: JTR (Kit, Quality Control For Culture Media)
- Device class: 1
- Regulation: 21 CFR 866.2480
- Recalls of this device: 40 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 2, 2025 · Class II · Z-0984-2026: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Dec 2, 2025 · Class II · Z-0985-2026: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Dec 2, 2025 · Class II · Z-0986-2026: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Jun 27, 2025 · Class II · Z-2194-2025: KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Jun 17, 2025 · Class II · Z-2124-2025: Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
- May 27, 2025 · Class II · Z-1957-2025: Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs
- Mar 6, 2024 · Class II · Z-1483-2024: The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliens
- Oct 18, 2023 · Class II · Z-0307-2024: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- Oct 18, 2023 · Class II · Z-0308-2024: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- Aug 14, 2023 · Class III · Z-2576-2023: One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
- May 6, 2022 · Class III · Z-1125-2022: Labeling error.
- Feb 24, 2021 · Class III · Z-0543-2022: Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
- Feb 24, 2021 · Class III · Z-0544-2022: Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
- Dec 16, 2020 · Class III · Z-0546-2022: The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 
- Dec 16, 2020 · Class II · Z-0511-2022: Contamination with S. epidermidis
- Oct 8, 2020 · Class II · Z-0302-2021: KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
- Oct 8, 2020 · Class II · Z-0303-2021: KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
- Oct 8, 2020 · Class II · Z-0304-2021: 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.
- Oct 8, 2020 · Class II · Z-0402-2021: Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
- Oct 8, 2020 · Class III · Z-0581-2022: The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was prin
- Oct 1, 2020 · Class II · Z-0582-2022: Potential contamination with S. epidermidis E. coli and S. warneri.
- Oct 1, 2020 · Class II · Z-0583-2022: Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
- Oct 1, 2020 · Class II · Z-0584-2022: Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
- Feb 18, 2020 · Class II · Z-0587-2022: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffu
- Feb 18, 2020 · Class II · Z-0589-2022: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffu
- Feb 18, 2020 · Class II · Z-0586-2022: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffu
- Feb 18, 2020 · Class II · Z-0588-2022: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffu
- Feb 18, 2020 · Class II · Z-0585-2022: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffu
- Feb 12, 2020 · Class II · Z-1691-2020: KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead
- Feb 12, 2020 · Class II · Z-1690-2020: KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead
- Mar 2, 2017 · Class III · Z-0636-2022: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
- Mar 2, 2017 · Class III · Z-0637-2022: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
- Dec 1, 2015 · Class II · Z-0704-2022: The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Stre
- Dec 1, 2015 · Class II · Z-0703-2022: The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Stre
- Jul 17, 2015 · Class III · Z-0788-2022: LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may
- Oct 6, 2014 · Class II · Z-0712-2022: This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
- Oct 6, 2014 · Class II · Z-0713-2022: This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
- Oct 6, 2014 · Class II · Z-0714-2022: This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
- Mar 25, 2013 · Class III · Z-0641-2022: Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C.
- Oct 12, 2007 · Not classified · Z-0456-2008: Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.

Source page: https://510kreport.com/device/K861022
Methodology: https://510kreport.com/methodology