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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83228

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

Open FDA event record

Event summary

Timeline bucket
June 17, 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

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 GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

Z-2202-2019
Recall number
Z-2202-2019
Initiated
June 17, 2019
Classification
Class II
Status
Terminated
Quantity
1099 (5 pack x 60)=329700 slides

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially Biased Results using VITROS Chemistry Products GLU Slides

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially Biased Results using VITROS Chemistry Products GLU Slides

Code information

Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572

Distribution pattern

US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN