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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

1000

Past Year

304

Class I (Serious)

Most Recent

Nov 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 4521–4540 of 4747 recalls

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

Roche Diagnostics Corp.: Roche brand Omni S2 Blood Gas Analyzer; Catalog # 0333711...

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

FDADec 9, 2005CA, FL, GA +10 more• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Omni S4 Blood Gas Analyzer; Catalog # 0333713...

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

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FDA

Dec 9, 2005

CA, FL, GA +10 more

• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Omni S6 Blood Gas Analyzer; Catalog # 0333715...

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

FDADec 9, 2005CA, FL, GA +10 more• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Elecsys total PSA, catalog number 11731262322.

There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.

FDADec 7, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Elecsys total PSA CalSet, catalog number 11731696322.

There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.

FDADec 7, 2005Nationwide• Roche Diagnostics Corp.

Abbott Laboratories Diagnostic Div: Clinical Chemistry Prealbumin, List Number 1E02-20

These specific protein assays are not meeting the 57-day on board stability claim

FDANov 10, 2005Nationwide• Abbott Laboratories Diagnostic Div

Abbott Laboratories Diagnostic Div: Clinical Chemistry Immunoglobulin M, List Number 1E01-20

These specific protein assays are not meeting the 57-day on board stability claim

FDANov 10, 2005Nationwide• Abbott Laboratories Diagnostic Div