—#102425

Product

MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. An automated instrument used for 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 the making of dilution series, reaction mixes.

FDA product code: LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Series 2.0 software version 1.1.23 and 1.1.24, Part number 05197686001, Ser Numbers LC2C00000383, LC2C00000566, LC2C00000572, LC2C00000428, LC2C00000482, LC2C00000266, LC2C00000192, LC2C00000216, LC2C00000233, LC2C00000419, LC2C00000531, LC2C00000033, LC2C00000583, LC2C00000127, LC2C00000170, LC2C00000563, LC2C00000234, LC2C00000561, LC2C00000205, LC2C00000394, LC2C00000329, LC2C00000418, LC2C00000420, LC2C00000569, LC2C00000570, LC2C00000564, LC2C00000486, LC2C00000483, LC2C00000158, LC2C00000214, LC2C00000215, LC2C00000265, LC2C00000309, LC2C00000217, LC2C00000254, LC2C00000081, LC2C00000159, LC2C00000212, LC2C00000213, LC2C00000293, LC2C00000427, LC2C00000232, LC2C00000242, LC2C00000134, LC2C00000168, LC2C00000219, LC2C00000479, LC2C00000228, LC2C00000580, LC2C00000243, LC2C00000263, LC2C00000393, LC2C00000155, LC2C00000203, LC2C00000204, LC2C00000267, LC2C00000268, LC2C00000193, LC2C00000206, LC2C00000381, LC2C00000381, LC2C00000429, LC2C00000588, LC2C00000449, LC2C00000218, LC2C00000253, LC2C00000110, LC2C00000156, LC2C00000128, LC2C00000162, LC2C00000178, LC2C00000118, LC2C00000079, LC2C00000273, LC2C00000431, LC2C00000477, LC2C00000196, LC2C00000130, LC2C00000310, LC2C00000264, LC2C00000414, LC2C00000276, LC2C00000312, LC2C00000313, LC2C00000361, LC2C00000363, LC2C00000331, LC2C00000330, LC2C00000236, LC2C00000360, LC2C00000294, LC2C00000298, LC2C00000532, LC2C00000220, LC2C00000270, LC2C00000413, LC2C00000120, LC2C00000274, LC2C00000227, LC2C00000384, LC2C00000275, LC2C00000364, LC2C00000269, LC2C00000252, LC2C00000119, LC2C00000250, LC2C00000235, LC2C00000169, LC2C00000244, LC2C00000108, LC2C00000256, LC2C00000272, LC2C00000173, LC2C00000582, LC2C00000064, LC2C00000255, LC2C00000179, LC2C00000562, LC2C00000581, LC2C00000035, LC2C00000080, LC2C00000172, LC2C00000412, LC2C00000032, LC2C00000131, LC2C00000195, LC2B00000042, LC2C00000039, LC2C00000043, LC2C00000034, LC2C00000132, LC2C00000133, LC2C00000060, LC2C00000180, LC2C00000578, LC2C00000314, LC2C00000571, 2C00000565, LC2C00000415, LC2C00000430, LC00000529, LC2C00000044, LC2C00000129, LC2C00000297, LC2C00000358, LC2C00000359, LC2C00000392 and LC2C00000434.

Why it was recalled

Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.

Root cause (FDA determination)

Other

Action the firm took

Roche Diagnostics Operations, Inc. sent a letter dated July 21, 2011 entitled "URGENT MEDICAL DEVICE CORRECTION" to all affected customers. The letter included the name product, software versions, and reason for recall and informed them the problem is under investigation. In the meantime, customers are asked to wait 30 seconds after the finalization of the decontamination cycle before initiating the next operation, in order to avoid this issue. For questions on this recall please call Roche at (800) 428-5074.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution; including the islands of Puerto Rico and Hawaii.

Timeline

Recall initiated: 2011-07-21
Posted by FDA: 2011-08-29
Terminated: 2012-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102425. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.