Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to…
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected…
Read the official notice →- Date
- 2023-07-19
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 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
- 2023-09-27
USOrtho-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 → - 2023-06-07
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data…
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide Foreign: Brazil, Chile, ColombiaOfficial notice → - 2023-05-31
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c…
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil…Official notice → - 2023-05-10
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil…Official notice →
Other drugs & medical recalls in the United States
- 2023-07-19
- US
Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the country of Panama.Official notice → - US
Stryker Medical Division of Stryker Corporation recalls Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled,…
Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.
FDA · DeviceStryker Medical Division of Stryker CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
Abiomed, Inc. recalls Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally…
- US
GE Vingmed Ultrasound As recalls GE Healthcare Vivid S60N, ultrasound device
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
- US
Medtronic Sofamor Danek USA Inc recalls Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral…
FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX,…Official notice →