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…
Read the official notice →- Date
- 2023-11-15
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per…
- Classification
- Class II
- Units
- US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-01-17
USOrtho-Clinical Diagnostics, Inc. recalls QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to…Official notice →- 2023-12-20
- US
Ortho-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.…
- 2023-10-11
- US
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…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution.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 →
Other drugs & medical recalls in the United States
- 2023-11-15
- US
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
FDA · DeviceStryker CorporationUS Nationwide. Australia, Canada, Japan, Korea, Singapore.Official notice → - US
Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
- US
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.
FDA · DeviceCHANGE HEALTHCARE CANADA COMPANYUS, Canada, Ireland, Saudi Arabia, France, UKOfficial notice → - US
Pulmonx, Corp. recalls Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
FDA · DevicePulmonx, Corp.US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX,…Official notice → - US
Breg Inc recalls BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
FDA · DeviceBreg IncU.S.: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI,…Official notice → - US
Philips North America recalls Allura Xper IGTS Fixed Systems
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer…
FDA · DevicePhilips North AmericaUnited States Territories of Puerto Rico, Guam, and Virgin IslandsOfficial notice →