Microbiologics Inc recalls LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single…
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Read the official notice →- Date
- 2022-02-16
- Country
- United States
- Brand
- Microbiologics
- Product
- LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single…
- Classification
- Class III
- Units
- International distribution in the countries of Canada and Germany.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-03-09
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 →- 2022-02-16
US
Microbiologics Inc recalls QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control…
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 diffusion method used…
FDA · DeviceMicrobiologics IncWorldwide Distribution. US nationwide including Puerto Rico and Guam,…Official notice →US
Microbiologics Inc recalls QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized…
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice →US
Microbiologics Inc recalls LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a…
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice →
Other drugs & medical recalls in the United States
- 2022-02-23
US
Organics Corporation of America DBA Ambix Laboratories recalls NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes,…
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
FDA · DrugOrganics Corporation of America DBA Ambix LaboratoriesThe product went to one consignee. Natural Organics, Inc., 548 Broadhollow…Official notice →US
Lannett Company, Inc. recalls Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc.,…
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
- 2022-02-17
US
Zeno Recalls Infant Walkers Due to Fall and Entrapment Hazards (Recall Alert)
The infant walkers fail to meet the federal safety standard. They can fit through a standard doorway and are not designed to stop at the edge of a step as required by the federal safety standard. The walkers also have…
- 2022-02-16
US
Smith & Nephew, Inc. recalls Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic…
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide distribution in the states of CO, CT,…Official notice →US
Synthes (USA) Products LLC recalls Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the…
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not…
US
MEDLINE INDUSTRIES, LP - Northfield recalls CURAD REUSABLE GEL HOT/COLD PACK
The product contains natural rubber latex but the label states that it does not.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, AnguillaOfficial notice →