Roche Hitachi System Analyzers recall in Canada: Inaccurate test results
In plain language
This recall involves Roche Hitachi System 704/717/747 Analyzers and various related reagents sold in Canada. They are being recalled because internal studies identified new interferences that could affect test results. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.
What to do
- Stop using the affected products immediately.
- Check the model and lot numbers against the recall notice.
- Contact Roche Diagnostics GMBH for updated method sheets and further instructions.
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Affected products
Roche Hitachi System 704/717/747 Analyzers - Class 2
Model: 10759350190
Lot: 29695701, 30558501, 30558801, 32402901, 32403201, 39993801
Cobas Integra Glucose HK Gen.3
Model: 4404483190
Lot: 37118201, 38172101, 39105101, 39929101, 40879901, 42138401, 43230301, 44444401
Cobas Integra Tina-Quant Albumin Gen.2
Model: 4469658190
Lot: 32279101, 34022301, 34852501, 36281701, 37742301, 39087401, 40384301, 41549301, 42591701, 44042501
Cobas C 111 Phosphorus (PHOS2)
Model: 05401780190
Lot: 37138201, 39515401, 42227901, 44681301
Cobas C 111 Uric Acid (UA2)
Model: 4657608190
Lot: 38914401, 41582001, 43133201
Cobas C 111 A-Amylase (AMYL2)
Model: 05401496190
Lot: 38408201, 40169901, 42941601, 44053901
Cobas C 111 CREJ2 - Creatinine Jaffe
Model: 05401755190
Lot: 31788801, 35247501, 38184001, 41615101
Cobas C 111 CREP2 - Creatinine Plus
Model: 05401470190
Lot: 39514801, 40633501, 41561401, 42448801
CO2-L (Bicarbonate Liquid) for Cobas C111 Analyzer
Model: 5061482190
Lot: 35776601, 36579401, 36759901, 39391901
CA2 (Calcium Gen.2)
Model: 5061504190
Lot: 36293901, 37154501, 40148501, 40821801, 42933501
PHOS2 (Phosphate (Inorganic) VER.2)
Model: 3183793122
Lot: 36040901, 38580801, 40875201, 40881101, 41738501, 42820301, 42857401, 44076201
TPUC3 (Total Protein Urine /CSF Gen.3)
Model: 3183742122, 3333825190
Lot: 36286301, 38650201, 40738901, 43134901, 38412101, 39928101, 41581501, 43654501
CO2-L (Bicarbonate Liquid)
Model: 3289923190
Lot: 32903701, 33635801, 36578401, 36756301, 36759201, 38892301, 39390701, 39391601, 40218901
AMY-P (Alpha-Amylase EPS Pancreatic)
Model: 20766623322
Lot: 38412701, 40445201, 41777001, 43655201
ETOH2 (Ethanol Gen.2)
Model: 3183777190
Lot: 42820301
CREP2 (Creatinine Plus Ver. 2)
Model: 3263991190
Lot: 38876501, 38981202, 40558001, 41817801, 42052701, 42284101, 43470801
CREJ2 (Creatinine Jaffe Gen. 2)
Model: 4810716190
Lot: More than 10 numbers, contact manufacturer.
UA2 (Uric Acid VER.2)
Model: 3183807190
Lot: 38427601, 41580001, 43180101
Why this matters
Inaccurate test results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 29695701, 30558501, 30558801, 32402901, 32403201, 39993801, 31788801, 35247501, 38184001, 41615101, 32279101, 34022301, 34852501, 36281701, 37742301, 39087401, 40384301, 41549301, 42591701, 44042501, 32903701, 33635801, 36578401, 36756301, 36759201, 38892301, 39390701, 39391601, 40218901, 35776601, 36579401, 36759901, 39391901, 36040901, 38580801, 40875201, 40881101, 41738501, 42820301, 42857401, 44076201, 36286301, 38650201, 40738901, 43134901, 36293901, 37154501, 40148501, 40821801, 42933501, 37118201, 38172101, 39105101, 39929101, 40879901, 42138401, 43230301, 44444401, 37138201, 39515401, 42227901, 44681301, 38408201, 40169901, 42941601, 44053901, 38412101, 39928101, 41581501, 43654501, 38412701, 40445201, 41777001, 43655201, 38427601, 41580001, 43180101, 38876501, 38981202, 40558001, 41817801, 42052701, 42284101, 43470801, 38914401, 41582001, 43133201, 39514801, 40633501, 41561401, 42448801, 42820301, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 05401470190, 05401496190, 05401755190, 05401780190, 10759350190, 20766623322, 3183742122, 3183777190, 3183793122, 3183807190, 3263991190, 3289923190, 3333825190, 4404483190, 4469658190, 4657608190, 4810716190, 5061482190, 5061504190
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Inaccurate test results
What should consumers do?
Stop using the affected products immediately. Check the model and lot numbers against the recall notice. Contact Roche Diagnostics GMBH for updated method sheets and further instructions.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Inaccurate test results
When was this product recalled?
This product was recalled on January 20, 2020.
Is the Roche Hitachi System brand affected by this recall?
Yes, Roche Hitachi System products are affected by this recall. This recall involves Roche Hitachi System 704/717/747 Analyzers and various related reagents sold in Canada. They are being recalled because internal studies identified new interferences that could affect test results. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.