Greiner Bio-One North America, Inc. recalls Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner…
Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the…
Read the official notice →- Date
- 2026-10-28
- Country
- United States
- Brand
- Greiner Bio-One
- Product
- Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Greiner Bio-One recalls
- 2025-11-26
Greiner Bio-One North America, Inc. recalls Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product…
Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat…
FDA · DeviceGreiner Bio-One North America, Inc.U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS,…Official notice →- 2025-11-05
Greiner Bio-One North America, Inc. recalls Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
- 2025-01-15
Greiner Bio-One GmbH recalls VACUETTE SAFELINK, REF: 450210
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
FDA · DeviceGreiner Bio-One GmbHUS Nationwide distribution in the states of IL, PA.Official notice →- 2024-07-24
Greiner Bio-One North America, Inc. recalls VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which…
FDA · DeviceGreiner Bio-One North America, Inc.Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA,…Official notice →- 2024-01-24
Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous…
FDA · DeviceGreiner Bio-One North America, Inc.US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA,…Official notice →- 2023-05-24
Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in…
Some of the tubes may be incorrectly labeled.
FDA · DeviceGreiner Bio-One North America, Inc.US Nationwide distribution in the states of WI and GA.Official notice →
USOther drugs & medical recalls in the United States
- 2026-10-28
Medtronic MiniMed, Inc. recalls CareLink Clinic, REF: MMT-7350
CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily…
Beckman Coulter, Inc. recalls ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846…
Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant…
Beckman Coulter, Inc. recalls ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846…
Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being…
Philips North America recalls Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC…
Axonics, Inc. recalls PNE Lead Implant Kit REF: 1701
Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
FDA · DeviceAxonics, Inc.US Nationwide distribution including in the states of FL, AL, NE, CA, NY,MI,…Official notice →Medtronic Navigation, Inc. recalls Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
FDA · DeviceMedtronic Navigation, Inc.US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY KY LA MA MD ME MI MN…Official notice →