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Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics Recalls

All product recalls associated with Ortho-Clinical Diagnostics.

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Recall Summary

Total Recalls

133

Past Year

Class I (Serious)

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 101–120 of 133 recalls

Ortho-Clinical Diagnostics: VITROS 4600 Chemistry System (VITROS 5,1 FS System family...

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Class IIModerate

FDANov 19, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS 5600 Integrated System, Catalog Number 6802413, IV...

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Class IIModerate

FDANov 19, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS 3600 Immunodiagnostic System, Catalog Number 6802...

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Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Class IIModerate

FDANov 19, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD ...

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

Class IIModerate

FDANov 6, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Software Version 3.1 utilized on the following sys...

Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.

Class IIILow

FDASep 29, 2014CO, MI, NJ +4 more• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS 4600 Chemistry System (VITROS 5,1 FS System family...

Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

Class IIModerate

FDASep 8, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS 5600 Integrated System, System Product Code 680241...

Class IIModerate

FDASep 8, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Pr...

Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.

Class IIModerate

FDAAug 20, 2014Nationwide• Ortho-Clinical Diagnostics

ORTHO-CLINICAL DIAGNOSTICS: VITROS Immunodiagnostic Products Anti-HCV Reagent Pack fo...

VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).

Class IIModerate

FDAAug 6, 2014CT, FL, GA +6 more• ORTHO-CLINICAL DIAGNOSTICS

ORTHO-CLINICAL DIAGNOSTICS: VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and...

Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.

Class IIModerate

FDAJul 16, 2014Nationwide• ORTHO-CLINICAL DIAGNOSTICS

Ortho-Clinical Diagnostics: VITROS¿ Chemistry Products CDM PROM Calibration Data Modu...

Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.

Class IIModerate

FDAJul 15, 2014IL, KY, MA +4 more• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS 5,1 FS (Fusion Series) Chemistry System Software V...

Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS Chemistry Products THC Reagent. A second customer complaint was received a month later. OCD's investigation concluded that under specific circumstances, incorrect qualitative results for Cannabi

FDAMay 17, 2007Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products Troponin I Reagent Pack,...

Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.

FDAApr 27, 2007Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom: VITROS Immunodiagnostics Products HBsAg Reagent Pack, Ca...

Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.

FDAFeb 1, 2007PR• Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom

Ortho-Clinical Diagnostics: VITROS Chemistry Products LIPA Slides GEN 48, Coating 32...

The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days.

FDAOct 9, 2006Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Chemistry Products GLU DT Slides GEN 56, REF (Cata...

Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.

FDASep 27, 2006Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products Signal Reagent, Catalog ...

Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.

FDAMar 28, 2006Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS WorkCentre, Catalog # 6802159, using enGen" Series...

Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)

FDAMar 6, 2006AZ, DE, MI +1 more• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 ...

Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.

FDADec 15, 2005Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm o...

Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.

FDAOct 12, 2005IN• Ortho-Clinical Diagnostics