Z-1651-2011

MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC...

Name: Z-1651-2011 MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC...
Creator: Roche Diagnostics Operations, Inc.
Published: 2010-10-26
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2010-10-26 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC 2.0 instrument is a robotic instrument for... on 2010-10-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1651-2011
Status: Terminated
Initiated: 2010-10-26
Posted: 2011-03-14
Terminated: 2011-08-30
Recalling firm: Roche Diagnostics GmbH
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.
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)