Ortho-Clinical Diagnostics, Inc. recalls Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry…
Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an…
Read the official notice →- Date
- 2023-10-11
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ortho-Clinical Diagnostics recalls
- 2023-12-20
USOrtho-Clinical Diagnostics, Inc. recalls VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen…
- 2023-12-13
- US
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively…
Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended.…
- 2023-11-15
- US
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18…
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed…
FDA · DeviceOrtho-Clinical Diagnostics, INc.US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France,…Official notice → - 2023-09-27
- US
Ortho-Clinical Diagnostics, INc. recalls VITROS XT Chemistry Products ALKP Slides
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to…Official notice → - 2023-08-16
- US
ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
FDA · DeviceORTHO-CLINICAL DIAGNOSTICSWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2023-08-02
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the…
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide distribution in the state of CA.Official notice →
Other drugs & medical recalls in the United States
- 2023-10-11
- US
Bard Peripheral Vascular Inc recalls Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA,…Official notice → - US
Becton Dickinson Infusion Therapy Systems Inc. recalls REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min ,…
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point…
FDA · DeviceBecton Dickinson Infusion Therapy Systems Inc.US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ,…Official notice → - US
Boston Scientific Corporation recalls Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the state of Indiana.Official notice → - US
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF…
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- US
Eugia US LLC recalls Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or…
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
- US
Imprimis NJOF, LLC recalls Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale.…
Subpotent: Failing Test Results for Epinephrine