Reported Jul 27, 2016 · Terminated
cobas¿ Liat¿ Analyzer
Roche Molecular Systems, 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 Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- cobas¿ Liat¿ Analyzer
- Lot codes and dates
- US-IVDM1-E-00383 & M1-E-00434
- Amount recalled
- 2
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
This product could cause temporary or reversible health problems — stop using it.
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