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Roche Diagnostics Corp.

Roche Diagnostics Corp. Recalls

All product recalls associated with Roche Diagnostics Corp..

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Recall Summary

Total Recalls

970

Past Year

46

Class I (Serious)

16

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 821–840 of 970 recalls

Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog numbe...

Incorrect patient blood glucose test results may be reported due to a software problem.

FDANov 9, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04...

Incorrect patient blood glucose test results may be reported due to a software problem.

FDANov 9, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Care Kit; Catalog number 0452...

Incorrect patient blood glucose test results may be reported due to a software problem.

FDANov 9, 2005Nationwide

1...40 414243 44...49

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• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Retail Distributor Pack; Cata...

Incorrect patient blood glucose test results may be reported due to a software problem.

FDANov 9, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Meter Only Kit; Catalog numbe...

Incorrect patient blood glucose test results may be reported due to a software problem.

FDANov 9, 2005Nationwide• Roche Diagnostics Corp.

Diagnostica Stago, Inc.: STA Liatest Free Protein S, cat. 00516. These kits are i...

The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.

FDAOct 26, 2005Nationwide• Diagnostica Stago, Inc.

Sonosite, Inc.: SonoCalc IMT 3.0, a windows based software used in conjun...

When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Underestimates percentage of stenosis, false negative result.

FDAOct 26, 2005Nationwide• Sonosite, Inc.

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

Louisville Apl Diagnostics Inc: APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distribute...

Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Louisville Apl Diagnostics Inc: APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distribute...

Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Louisville Apl Diagnostics Inc: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; dist...

Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Nichols Institute Diagnostics: Nichols Advantage EPO Calibration Verifiers, Catalog #63-...

Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2.

FDASep 30, 2005CA, IN, WA• Nichols Institute Diagnostics

Ortho-Clinical Diagnostics: Vitros ECi Immunodiagnostic System, sold as Cat. #863 389...

When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negtively biased.

FDASep 29, 2005Nationwide• Ortho-Clinical Diagnostics

Nichols Institute Diagnostics: Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) As...

Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

FDAAug 31, 2005Nationwide• Nichols Institute Diagnostics

Nichols Institute Diagnostics: Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay...

Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

FDAAug 31, 2005Nationwide• Nichols Institute Diagnostics

Trek Diagnostic Systems: VersaTREK Myco AS.

Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.

FDAAug 8, 2005AL, IL, IN +6 more• Trek Diagnostic Systems

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E...

The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.

FDAAug 5, 2005Nationwide• Abbott Laboratories Diagnostic Div

Ortho-Clinical Diagnostics: VITROS Chemistry GENT Reagent REF 680 1711, *** Responsib...

Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.

FDAJul 19, 2005Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803;...

The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.

FDAJul 15, 2005Nationwide• Roche Diagnostics Corp.

Diagnostica Stago, Inc.: STA-R blood coagulation analyzer. Catalog Number 57160.

Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.

FDAJun 20, 2005Nationwide• Diagnostica Stago, Inc.