Roche Diagnostics Operations, Inc.: 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.

Recall number

Z-1651-2011

Recalling firm

Roche Diagnostics Operations, Inc.

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.

Status

Terminated

Initiated

2010-10-26

Posted

2011-03-14

Terminated

2011-08-30

Reason

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

Software design

Action

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.

Quantity

119 devices

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OOI

Firm FEI

1823260

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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