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…
Read the official notice →- Date
- 2022-03-23
- Country
- United States
- Brand
- Microbiologics
- Product
- LYFO Disk
- Classification
- Class III
- Units
- Distribution is nationwide with three consignees located in Colorado, Georgia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-04-27
US
Microbiologics Inc recalls Inactivated macrolide-resistant Mycoplasma genitalium
The QC process was not adequate for the specification range.
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of NV and VT.Official notice →US
Microbiologics Inc recalls Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
QC process was not adequate for the specification range.
- 2022-04-06
US
Microbiologics 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 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 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.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →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 →
Other drugs & medical recalls in the United States
- 2022-03-23
US
CellEra LLC recalls 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the…
US
Bard Peripheral Vascular Inc recalls LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
FDA · DeviceBard Peripheral Vascular IncU.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA,…Official notice →US
Sam Medical Products recalls SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an…
FDA · DeviceSam Medical ProductsU.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA…Official notice →US
LivaNova Deutschland GmbH recalls Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System…
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
US
Wright Medical Technology, Inc. recalls Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC…
An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
FDA · DeviceWright Medical Technology, Inc.International distribution to the country of France.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 →