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Terminated

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

FDA Recall Z-0614-2013 · Posted 2012-12-23

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeJJH
Date Initiated2012-10-11
Date Terminated2013-09-11
Product Quantity7 units

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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