Reported Oct 23, 2019 · Terminated
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative…
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?
- Cobas c Bilirubin Total Gen.3
- Catalog Number05795419190 -
- Product UsageIn vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems
- Lot codes and dates
- Lot # 36133801
- Amount recalled
- 2,304 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
Why it was recalled
Due to low Quality Control recovery and invalid Calibration.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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