Reported Oct 21, 2020 · Terminated
Tina-quant Complement C4 ver.2, Catalog 05991994190
Roche Diagnostics Operations, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
Tina-quant Complement C4 ver.2Catalog 05991994190
- Lot codes and dates
- lot 36870301
- Amount recalled
- 180 units
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
- Nationwide
Why it was recalled
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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