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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

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 841–860 of 970 recalls

Roche Diagnostics Corp.: ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit i...

The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.

FDAJun 7, 2005Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: Vitros Chemistry CRBM Slides, REF 889 2382. There are 90...

Falsely elevated Carbamazepine results.

FDAMay 26, 2005Nationwide• Ortho-Clinical Diagnostics

Diagnostic Products Corp: Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LK...

Adverse trend in stability, controls biased or out of range.

FDAMay 26, 2005

1...41 424344 45...49

Page 43 of 49Next

Nationwide

• Diagnostic Products Corp

Provalis Diagnostics: Product is in2it A1C In-Office Analyzer Test Cartridge. ...

Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.

FDAMay 20, 2005AZ, FL, GA +5 more• Provalis Diagnostics

Roche Diagnostics Corp.: ACCU-CHEK Compact Care Kit; catalog number 3149137.

The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.

FDAMay 18, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.

The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.

FDAMay 18, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: ACCU-CHEK Instant Care Kit; Catalog number 91490.

FDAMay 18, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: ACCU-CHEK Compact Meter; catalog number 3183572.

FDAMay 18, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostic HealthWear brand Professional System for...

Lack of adequate manufacturing controls.

FDAMay 3, 2005Nationwide• Roche Diagnostics Corp.

Nichols Institute Diagnostics: Nichols Advantage Sample hGH Diluent Set (Catalog No. 62...

Under recovery of diluted samples by as much as 20%.

FDAMay 2, 2005Nationwide• Nichols Institute Diagnostics

Nichols Institute Diagnostics: Nichols Advantage TSH - Third Generation

Does not meet performance claims in the labeling.

FDAApr 28, 2005Nationwide• Nichols Institute Diagnostics

Venoscope LLC: Venoscope Neonatal Transilluminator, Model NT01

Excessive heating due to incorrect wire assembly process.

FDAApr 28, 2005Nationwide• Venoscope LLC

Nichols Institute Diagnostics: Nichols Advantage ACTH Test System, catalog number 62-7004.

Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.

FDAApr 22, 2005Nationwide• Nichols Institute Diagnostics

Roche Diagnostics Corp.: Roche brand AccuData GTS/GTS Plus System Replacement Base...

If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

FDAApr 18, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand AccuData GTS Plus System; Catalog number 3000...

FDAApr 18, 2005Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: VITROS VALP Reagent , REF 680 1710. Each box contains 6 ...

Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.

FDAApr 18, 2005Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Roche brand AccuData GTS System; Catalog number 404, mate...

FDAApr 18, 2005Nationwide• Roche Diagnostics Corp.

Nichols Institute Diagnostics: Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH As...

Controls were out of specification range.

FDAApr 14, 2005Nationwide• Nichols Institute Diagnostics

Diagnostica Stago, Inc.: PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Dia...

Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

FDAApr 13, 2005Nationwide• Diagnostica Stago, Inc.

Nichols Institute Diagnostics: Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040

Values do not agree with Directional Instructions.

FDAApr 7, 2005Nationwide• Nichols Institute Diagnostics