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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86669

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 16, 2020
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Ortho Clinical Diagnostics 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

1 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 1

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Z-0471-2021
Recall number
Z-0471-2021
Initiated
October 16, 2020
Classification
Class III
Status
Ongoing
Quantity
10788 total: US 4680; OUS 6108

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Code information

Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.