Recall events
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Event 63312
Event summary
Timeline bucket July 16, 2012
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Roche Molecular Systems, Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
10 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 10
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Z-0484-2013
Recall number Z-0484-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 884 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0484-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[19809]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16024]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 10
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
Z-0485-2013
Recall number Z-0485-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 816 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0485-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[54083]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[15992]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 10
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Z-0486-2013
Recall number Z-0486-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 13 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0486-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25818]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[21011]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 10
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
Z-0487-2013
Recall number Z-0487-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 3,772 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0487-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[1497]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16282]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 10
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
Z-0488-2013
Recall number Z-0488-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 1,213 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0488-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48843]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16367]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 10
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Z-0489-2013
Recall number Z-0489-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 77 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0489-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[36990]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16014]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 10
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Z-0490-2013
Recall number Z-0490-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 855 units.
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0490-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6634]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[16302]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 10
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Z-0491-2013
Recall number Z-0491-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 1,015 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0491-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[54082]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24454]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 10
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Z-0492-2013
Recall number Z-0492-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 479 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0492-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[19807]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19492]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0493-2013
Initiated July 16, 2012
Classification Class II
Status Terminated
Quantity 126 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software issue
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0493-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[19811]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information Device-associated diagnostic software
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[21009]
FDA event record
· Exact recall-number query on openFDA
