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…
Read the official notice →- Date
- 2024-01-24
- Country
- United States
- Brand
- Greiner Bio-One
- Product
- VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-11-05
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 → - 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 → - 2021-10-06
- US
Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Blood collection tubes may experience a clotting issue.
FDA · DeviceGreiner Bio-One North America, Inc.Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-01-24
- US
Becton Dickinson & Company recalls PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in…
FDA · DeviceBecton Dickinson & CompanyUS Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,…Official notice → - US
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Toric II OptiBlue IOL Models ZCW
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.International distribution to the country of Japan.Official notice → - US
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which…
FDA · DeviceAbbott Diabetes Care, Inc.US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX,…Official notice → - US
Philips North America recalls (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model…
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
FDA · DevicePhilips North AmericaWorldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN,…Official notice → - US
Oakworks Inc recalls Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back…
Backrest platform stress fracture - the table is not operational in an inclined position
- US
Limacorporate S.p.A recalls PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.