Reported Dec 25, 2019 · Terminated
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi
- cobas c systems Catalog Number06542921190 - -
- Product UsageThe assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria
- Lot codes and dates
- Lot Number422313
- Exp Date07/31/2020
- Amount recalled
- 82 units (US)
Where it was sold
Why it was recalled
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
This product could cause temporary or reversible health problems — stop using it.
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