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…
Read the official notice →- Date
- 2025-11-26
- Country
- United States
- Brand
- Greiner Bio-One
- Product
- Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner…
- Classification
- Class II
- Units
- U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-11-05
USGreiner 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
- US
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
- US
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
- US
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
- US
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 → - 2022-01-26
- US
Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs.,…
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
FDA · DeviceGreiner Bio-One North America, Inc.Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-03
- US
Medical Products Laboratories, Inc. recalls Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL…
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
- 2025-11-26
- US
Sterilmed, Inc. recalls Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC…
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or…
FDA · DeviceSterilmed, Inc.United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New…Official notice → - US
Olympus Corporation of the Americas recalls Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy…
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were…
FDA · DeviceOlympus Corporation of the AmericasUS Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.Official notice → - US
Meridian Bioscience Inc recalls Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
FDA · DeviceMeridian Bioscience IncUS Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN,…Official notice → - US
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402…
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
FDA · DeviceASP Global, LLC. dba Anatomy Supply Partners, LLC.Distribution US nationwide and Canada.Official notice → - US
Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
FDA · DeviceAuris Health, IncNationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA,…Official notice →