Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
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.
Read the official notice →- Date
- 2022-03-09
- Country
- United States
- Brand
- Microbiologics
- Product
- KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Argentina,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-04-06
USMicrobiologics Inc recalls Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria…
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
FDA · DeviceMicrobiologics IncUS distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania,…Official notice →- 2022-03-23
- US
Microbiologics Inc recalls LYFO Disk
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 cause a user's…
FDA · DeviceMicrobiologics IncDistribution is nationwide with three consignees located in Colorado, Georgia,…Official notice → - US
Microbiologics Inc recalls Mycoplasma genitalium Control Panel (Inactivated Pellet)
Distributed product did not undergo proper release testing.
FDA · DeviceMicrobiologics IncDistribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY,…Official notice → - 2022-03-09
- US
Microbiologics Inc recalls QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb)…
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 Streptococcus (GBS) in…
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL,…Official notice → - US
Microbiologics Inc recalls Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets…
Real-time shelf life testing failed at 24 months
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AK, CA,…Official notice → - 2022-02-23
- US
Microbiologics Inc recalls KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
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. coli, indicating…
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Canada, South…Official notice →
Other drugs & medical recalls in the United States
- 2022-03-09
- US
Orthosoft, Inc. dba Zimmer CAS recalls NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical…
FDA · DeviceOrthosoft, Inc. dba Zimmer CASWorldwide distribution - US Nationwide distribution in the states of AR, NY,…Official notice → - US
Sunstar Americas, Inc. recalls BUTLER Clear Dip, 12 bottles/case
Product lacks premarket clearance.
- US
Stryker Leibinger GmbH & Co. KG recalls MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
- US
Hobbs Medical, Inc. recalls Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush…
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
- US
Abbott Molecular, Inc. recalls Alinity m Integrated Reaction Units (IRU)
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
FDA · DeviceAbbott Molecular, Inc.US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL,…Official notice → - US
Lacrimedics Inc recalls Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
FDA · DeviceLacrimedics IncNationwide and Worldwide Distribution to following countries - AR. BE, BO, BR,…Official notice →