Bulk Loader Module for cobas p 512/612 Pre-analytical recall: Contamination
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In…
Why was Bulk Loader Module for cobas p 512/612 Pre-analytical recalled?
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
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?
During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.
- Product
- Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 1
- Distribution
- Distributed to TX only.
- Recall date
- November 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)