Beckman Coulter, Inc. recalls Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access…
An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay…
Read the official notice →- Date
- 2023-03-22
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access…
- Classification
- Class II
- Units
- Worldwide and Nationwide Distribution. There was government/military…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls
- 2023-05-24
USBeckman Coulter Inc. recalls Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
FDA · DeviceBeckman Coulter Inc.Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →- US
Beckman Coulter, Inc. recalls DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
- 2023-04-26
- US
Beckman Coulter, Inc. recalls Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - 2023-01-11
- US
Beckman Coulter, Inc. recalls BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN…
FDA · DeviceBeckman Coulter, Inc.US and Canada, Brazil, Korea, Mexico, Puerto Rico, TaiwanOfficial notice → - 2022-11-30
- US
Beckman Coulter, Inc. recalls MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI…Official notice → - 2022-05-25
- US
Beckman Coulter Inc. recalls MicroScan WalkAway-40 plus Instrument REF B1018-283
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
FDA · DeviceBeckman Coulter Inc.Worldwide distribution - U.S. Nationwide distribution in the states of Alaska,…Official notice →
Other drugs & medical recalls in the United States
- 2023-03-22
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if…
FDA · DeviceBard Peripheral Vascular IncWorldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO,…Official notice → - US
Brainlab AG recalls Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
FDA · DeviceBrainlab AGUS Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus…
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile…Official notice → - US
Stryker Medical Division of Stryker Corporation recalls Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency…
Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement…
FDA · DeviceStryker Medical Division of Stryker CorporationUS Nationwide distribution in the states of NY, VA.Official notice → - US
Fenwal Inc recalls Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
FDA · DeviceFenwal IncNationwide distribution. International distribution to France, Korea, Taiwan,…Official notice → - US
BioFire Diagnostics, LLC recalls In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping…
FDA · DeviceBioFire Diagnostics, LLCU.S. Nationwide distribution in the states of FL and GA.Official notice →