The Binding Site Group, Ltd. recalls Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10)…
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6…
Read the official notice →- Date
- 2021-12-01
- Country
- United States
- Brand
- Binding Site Group
- Product
- Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF…
- Classification
- Class II
- Units
- U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Binding Site Group recalls
- 2026-06-17
US
The Binding Site Group, Ltd. recalls Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description:…
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed…
Other drugs & medical recalls in the United States
- 2021-12-01
US
Philips North America Llc recalls Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or…
Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or…
FDA · DevicePhilips North America LlcUS (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to…Official notice →US
Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or…
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →US
Intuitive Surgical, Inc. recalls The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision…
Incorrect expiration date on its package labeling (shipper box and inner carton label).
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA,…Official notice →US
Medtronic Perfusion Systems recalls Cardioblate CryoFlex Surgical Ablation Console
There is potential for intermittent electrical connectivity between the console and probe.
FDA · DeviceMedtronic Perfusion SystemsDistribution in US - IL, KS, and UT Distribution outside of US to Australia…Official notice →US
Abbott Laboratories recalls ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash…
FDA · DeviceAbbott LaboratoriesU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →US
Western/Scott Fetzer Company recalls Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke