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
Reported: January 2, 2013 Initiated: October 11, 2012 #Z-0614-2013
Product Description
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
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.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 7 units
- Distribution
- Distributed in the states of GA, CA, NC, and MN.
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roche Molecular Systems, Inc.. Units affected: 7 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2013. Severity: Moderate. Recall number: Z-0614-2013.
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