COBAS AmpliPrep Instrument recall: Software Issue
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche…
Why was COBAS AmpliPrep Instrument recalled?
Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.
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?
CAP 394436 to 394663
- Product
- COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche…
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 7 units
- Distribution
- Distributed in the states of GA, CA, NC, and MN.
- Recall date
- January 2, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)