Recall events
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Event 82784
Event summary
Timeline bucket April 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
4 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 4
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Z-1933-2019
Recall number Z-1933-2019
Initiated April 08, 2019
Classification Class II
Status Terminated
Quantity 5020 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1933-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10690]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Distribution pattern US 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[28432]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Z-1934-2019
Recall number Z-1934-2019
Initiated April 08, 2019
Classification Class II
Status Terminated
Quantity 57 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1934-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21556]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Distribution pattern US 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[28436]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Z-1935-2019
Recall number Z-1935-2019
Initiated April 08, 2019
Classification Class II
Status Terminated
Quantity 2411 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1935-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27015]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Distribution pattern US 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[29048]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Z-1936-2019
Recall number Z-1936-2019
Initiated April 08, 2019
Classification Class II
Status Terminated
Quantity 3889 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1936-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45739]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Distribution pattern US 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[29132]
FDA event record
· Exact recall-number query on openFDA
