Reported Mar 14, 2018 · Terminated
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Roche Diagnostics Corporation
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 Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas 8000 Modular Analyzer Series
- Part Numbers1. 05964067001 cobas 8000 c 502 module
- Lot codes and dates
- Serial Numbers
245 of 245 codes
16C4-091475-011476-0515A1-0315A1-0516B3-101474-061138-101140-101485-061590-011475-051484-051484-061012-061482-021481-101254-071487-071482-091482-1016B7-0816B8-061010-031020-0915A2-021247-021267-0615A2-031267-011369-0216B5-0816B3-0315A5-0415A5-031124-031125-041591-041591-051474-091474-081009-051021-081139-031140-091267-021267-031140-0616B1-0216B1-031138-041138-0916B4-0316C3-031485-071597-091011-101018-1016C7-0816C4-07
- Serial Numbers
- Amount recalled
- 245
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
A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
This product could cause temporary or reversible health problems — stop using it.
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.
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