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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68271

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 10, 2014
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

3 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 3

VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.

Z-1734-2014
Recall number
Z-1734-2014
Initiated
April 10, 2014
Classification
Class II
Status
Terminated
Quantity
Domestic - 82, Foreign - 213 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Code information

Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403

Distribution pattern

Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

device · product 2 of 3

VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.

Z-1735-2014
Recall number
Z-1735-2014
Initiated
April 10, 2014
Classification
Class II
Status
Terminated
Quantity
Domestic - 835 units, Foreign - 921 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Code information

Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912

Distribution pattern

Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

device · product 3 of 3

VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.

Z-1736-2014
Recall number
Z-1736-2014
Initiated
April 10, 2014
Classification
Class II
Status
Terminated
Quantity
Domestic - 597 units, Foreign - 1381 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Code information

Software Version 2.7 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000102 through J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: ¿34000337, ¿34001840, ¿34000316, ¿34001389, 34001317, ¿34000538, ¿34000552, ¿34000360, ¿34000451, ¿34000833, ¿ 34001572, ¿34000193, ¿34001633, ¿34000851, ¿34001345, ¿34001396, 34001809, ¿34001897, ¿34001240, ¿34001612, ¿34001311, ¿34000212, 34001472, ¿34001172, ¿34001390, ¿34000557, ¿34000893, ¿34001297, 34001378, ¿34001218, ¿34000318, ¿34000596, ¿34000497, ¿34000495, 34000529, ¿34000478, ¿34001569, ¿34001243, ¿34001504, ¿34000947, 34001422, ¿34000805, ¿34000631, ¿34001248, ¿34001251, ¿34000601, 34001274, ¿34001668, ¿34001850, ¿34001379, ¿34000133, ¿34000642, 34001626.

Distribution pattern

Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.