Overview of recall records associated with Ortho-Clinical Diagnostics, including dates, categories and classifications where available.
Classification mix: Class II: 89, Class III: 14.
CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results…
Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for…
The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The…
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS…
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS…
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS…
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS…
There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality…
Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug…
Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit…
Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry…
Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially…
If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive…
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect…
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead…
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead…
When testing was conducted using certain lots, VITROS Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to…
The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to…
The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the…
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding…
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding…
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding…
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding…
This page summarizes recall records in which the official source identifies Ortho-Clinical Diagnostics as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
