FDAClass IIAugust 22, 2012

COBAS AmpliPrep Sample Tube Input Barcode Clips recall

COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep…

Why was COBAS AmpliPrep Sample Tube Input Barcode Clips recalled?

Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if the issue occurs, but samples in proce

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?

Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.

Product
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep…
Recalling firm
Roche Molecular Systems, Inc.
Quantity
2,132 boxes
Distribution
Nationwide Distribution (USA).
Recall date
August 22, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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