Reported Oct 23, 2019 · Terminated
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the…
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?
- Roche Diagnostics cobas Integra Albumin Gen.2
- Catalog Number05166861190 -
- Product UsageIn vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems
- Lot codes and dates
- Lot # 33962301. Expanded on 12/20/19 to include lot 37437301
- Amount recalled
- 7,032 units (Expanded on 12/20/19 to include 29,696 additional 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Roche Diagnostics Operations, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.