COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with C

FDA device recall Z-0614-2013 · posted 2012-12-23 · Terminated

Recall details

Recalling firm

Roche Molecular Systems, Inc.

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.

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.

Root cause

Device Design

Status

Terminated

Product code

JJH

Quantity affected

7 units

Distribution

Distributed in the states of GA, CA, NC, and MN.

Date initiated

2012-10-11

Date posted

2012-12-23

Date terminated

2013-09-11

Location

S Branchburg, NJ