Recall events
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Event 83322
Event summary
Timeline bucket July 08, 2019
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Ortho Clinical Diagnostics
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
12 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 12
VITROS 250 Chemistry System, clinical chemistry analyzer
Z-2174-2019
Recall number Z-2174-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 30
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2174-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27246]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 8132086 UDI: 10758750004409 Affected software : Version 9.7
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[28422]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 12
VITROS 250 Chemistry System, clinical chemistry analyzer
Z-2175-2019
Recall number Z-2175-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 2
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2175-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56463]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6801759 (Refurbished) UDI: 10758750001330 Affected software : Version 9.7
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[29188]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 12
VITROS 250AT Chemistry System, clinical chemistry analyzer
Z-2176-2019
Recall number Z-2176-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 30
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2176-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38652]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 1758143 UDI: 10758750000036 Affected software : Version 9.7
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[28350]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 12
VITROS 350 Chemistry System, clinical chemistry analyzer
Z-2177-2019
Recall number Z-2177-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 30
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2177-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10697]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6802153 UDI: 10758750002054 Affected software : Version 9.7
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[28899]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 12
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Z-2178-2019
Recall number Z-2178-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2178-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44580]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6844508 UDI: 10758750032105
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[29258]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 12
VITROS 5600 Integrated System, clinical chemistry analyzer
Z-2179-2019
Recall number Z-2179-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 2531
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2179-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33115]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6802413 UDI: 10758750002740 Affected software : Version 3.3.2 or above
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[28320]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 12
VITROS 5600 Integrated System, clinical chemistry analyzer
Z-2180-2019
Recall number Z-2180-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 89
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2180-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33094]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6802915 UDI: 10758750007110 Affected software : Version 3.3.2 or above
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[29249]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 12
VITROS 4600 Chemistry System, clinical chemistry analyzer
Z-2181-2019
Recall number Z-2181-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 825
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2181-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27237]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6802445 UDI: 10758750012343 Affected software : Version 3.3.2 or above
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[29076]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 12
VITROS 4600 Chemistry System, clinical chemistry analyzer
Z-2182-2019
Recall number Z-2182-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 9
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2182-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33099]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6900440 UDI: 10758750033201 Affected software : Version 3.3.2 or above
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[29105]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2183-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 1051
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2183-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15277]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code: 6801375 UDI: 10758750001132 Affected software : Version 3.1 or above
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[28881]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2184-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity 55
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2184-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15273]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code:6801890 UDI: 10758750001644 Affected software : Version 3.1 or above
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[29084]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2185-2019
Initiated July 08, 2019
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Software Anomaly
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-2185-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44578]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information product code:6844508 UDI: 10758750032105 Affected Assay Data Disk (ADD) DRV No: DRV 6032 or above
Distribution pattern Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
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[29129]
FDA event record
· Exact recall-number query on openFDA
