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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97034

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

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Event summary

Timeline bucket
June 12, 2025
Product types
Device
Classifications
Class II
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 OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.

Z-2073-2025
Recall number
Z-2073-2025
Initiated
June 12, 2025
Classification
Class II
Status
Ongoing
Quantity
2,017 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.

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

Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.

Code information

Model Number: 680 1997. UDI-DI: 10758750001835. Lot Numbers: 1527-15-2749 (exp. 17-Nov-2025), 1527-15-2771 (exp. 17-Dec-2025), 1527-15-2818 (exp. 11-Apr-2026), 1527-15-2871 (exp. 15-May-2026).

Distribution pattern

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