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…
Read the official notice →- Date
- 2022-02-23
- Country
- United States
- Brand
- Microbiologics
- Product
- KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
- Classification
- Class III
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, South…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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 →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 →- 2022-02-16
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 →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 →
Other drugs & medical recalls in the United States
- 2022-02-23
US
Oscor Inc. recalls Destino Twist 14F (also branded as Guidestar 14F)
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
FDA · DeviceOscor Inc.Distribution to TN and PA in USA OUS distribution to Czech RepublicOfficial notice →US
Howmedica Osteonics Corp. recalls 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Puerto Rico and the countries of Canada, and…Official notice →US
Envisiontec US Llc recalls FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
US
Hill-Rom, Inc. recalls Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
FDA · DeviceHill-Rom, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Austria,…Official notice →US
Olympus Corporation of the Americas recalls OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible…
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent…
US
TELEFLEX MEDICAL INC recalls Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The…
The firm received reports indicating PTD tip separation during use.
FDA · DeviceTELEFLEX MEDICAL INCWorldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ,…Official notice →