Cobas c8000 Modular Analyzer Series Cobas c502 recall
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative /…
Why was Cobas c8000 Modular Analyzer Series Cobas c502 recalled?
The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
not applicable
- Product
- Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative /…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 76 units
- Distribution
- USA Nationwide Distribution including San Juan PR
- Recall date
- April 16, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)