Microbiologics Inc recalls KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
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.
Read the official notice →- Date
- 2025-07-23
- Country
- United States
- Brand
- Microbiologics
- Product
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- Classification
- Class II
- Units
- US distribution to states of: Utah and Ohio; and OUS (International) to…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Microbiologics recalls
- 2025-12-31
USMicrobiologics Inc recalls KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- 2025-12-10
- US
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
FDA · DeviceMicrobiologics IncInternational distribution to the countries of UAE, China, Singapore,…Official notice → - 2025-08-06
- US
Microbiologics Inc recalls LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
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.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of France, Colombia,…Official notice → - 2025-06-18
- US
Microbiologics Inc recalls KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K,…
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. This may lead to…
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of California and Pennsylvania and…Official notice → - 2025-04-02
- US
Microbiologics Inc recalls Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control…
The RSV target may give a late Ct value and could potentially not pass QC.
FDA · DeviceMicrobiologics IncWorldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and…Official notice → - 2025-03-26
- US
Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog…
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Other drugs & medical recalls in the United States
- 2025-07-30
- US
Imprimis NJOF, LLC recalls Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only,…
Sub-Potent Drug: Subpotent assay results during stability testing.
- 2025-07-23
- US
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure…
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a…
- US
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711…
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
FDA · DeviceEncore Medical, LPU.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806…
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution;…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD,…Official notice → - US
Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description:…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
FDA · DeviceWaismed Ltd.Worldwide distribution: US (nationwide) to state of: NC and OUS…Official notice → - US
ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of TX, SD, ID,…Official notice →