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
Read the official notice →- Date
- 2022-03-09
- Country
- United States
- Brand
- Microbiologics
- Product
- Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AK, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-03-23
USMicrobiologics 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 → - 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 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.
FDA · DeviceMicrobiologics IncInternational distribution in the countries of Canada and Germany.Official notice → - 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 →
Other drugs & medical recalls in the United States
- 2022-03-09
- US
K2M, Inc recalls Everest MI XT Inner Dilator, Catalog Number 5101-90167
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were…
- 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
Intuitive Surgical, Inc. recalls da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is…
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Panama and Bermuda.Official notice → - US
ROi CPS LLC recalls Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Products are mislabeled with the incorrect product identification on individual kit labeling.
- US
Beckman Coulter Inc. recalls AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is…
FDA · DeviceBeckman Coulter Inc.US: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut,…Official notice →