COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
This recall has been terminated (originally issued December 23, 2012).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- October 11, 2012
- Posted
- December 23, 2012
- Terminated
- September 11, 2013
- Recall Number
- Z-0614-2013
- Quantity
- 7 units
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed in the states of GA, CA, NC, and MN.
Lot / Code Info
CAP 394436 to 394663
Root Cause
Device Design
Action Taken
Roche sent an Urgent Medical Device Correction notification/Fax Back forms dated 10/11/12 to potentially affected customers. The letter identified the affected product, the issue, clinical significance, workaround, and required actions, along with contact information. Customers are to use the workaround until their Roche FSE has performed a Master Initialization on their affected instruments. Also, the letter should be filed for future reference. Questions should be directed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.