—#96478

Product

MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, total RNA , total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96 well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for making of dilution series, reaction mixes.

FDA product code: OOI — Real Time Nucleic Acid Amplification System
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: LC2C00000032, LC2C00000033, LC2C00000035, LC2C00000060, LC2C00000064, LC2C00000079, LC2C00000080, LC2C00000081, LC2C00000108, LC2C00000110, LC2C00000118, LC2C00000119, LC2C00000120, LC2C00000127, LC2C00000128, LC2C00000130, LC2C00000131, LC2C00000132, LC2C00000133, LC2C00000134, LC2C00000155, LC2C00000156, LC2C00000158, LC2C00000159, LC2C00000162, LC2C00000168, LC2C00000169, LC2C00000170, LC2C00000172, LC2C00000173, LC2C00000178, LC2C00000179, LC2C00000180, LC2C00000192, LC2C00000193, LC2C00000195, LC2C00000196, LC2C00000203, LC2C00000204, LC2C00000205, LC2C00000206, LC2C00000212, LC2C00000213, LC2C00000214, LC2C00000215, LC2C00000216, LC2C00000217, LC2C00000218, LC2C00000219, LC2C00000220, LC2C00000227, LC2C00000228, LC2C00000232, LC2C00000233, LC2C00000234, LC2C00000235, LC2C00000236, LC2C00000242, LC2C00000243, LC2C00000244, LC2C00000250, LC2C00000252, LC2C00000253, LC2C00000254, LC2C00000255, LC2C00000256, LC2C00000263, LC2C00000264, LC2C00000265, LC2C00000266, LC2C00000267, LC2C00000268, LC2C00000269, LC2C00000270, LC2C00000272, LC2C00000273, LC2C00000274, LC2C00000275, LC2C00000276, LC2C00000293, LC2C00000294, LC2C00000298, LC2C00000309, LC2C00000310, LC2C00000312, LC2C00000313, LC2C00000314, LC2C00000329, LC2C00000330, LC2C00000331, LC2C00000358, LC2C00000359, LC2C00000360, LC2C00000361, LC2C00000363, LC2C00000364, LC2C00000381, LC2C00000384, LC2C00000392, LC2C00000393, LC2C00000394, LC2C00000412, LC2C00000413, LC2C00000414, LC2C00000415, LC2C00000418, LC2C00000419, LC2C00000420, LC2C00000427, LC2C00000429, LC2C00000430, LC2C00000431, LC2C00000449, LC2C00000479, LC2C00000483, LC2C00000486, LC2C00000563, LC2C00000571 and LC2C00000578.

Why it was recalled

If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. This may result in sample mis identification. If printed from the ordering screens, the bar code is printed with the correct batch ID.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 04, 2010 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to print batch ID barcode labels from the ordering or stage set up screens only; print Cooling Block barcode labels from the Post Elution Edit screen only; complete and return the attached UMDC Faxback Form for MagNA Pure LC 2.0 Instrument [UMDC 10-228] via fax to 1-877-551-7152 and file this correction notice for future reference. The firm plans to issue a software update in first quarter 2011. If you have questions about the information contained in this UMDC, for Clinical customers, please contact Roche Molecular Diagnostics Technical Service at 1-800-526-1247; for Research customers, please contact Roche Applied Sciences Technical Service at 1-800-262-4911.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Road, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.

Timeline

Recall initiated: 2010-10-26
Posted by FDA: 2011-03-14
Terminated: 2011-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.