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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86038

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

Open FDA event record

Event summary

Timeline bucket
July 17, 2020
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

2 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 2

VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Z-2770-2020
Recall number
Z-2770-2020
Initiated
July 17, 2020
Classification
Class II
Status
Terminated
Quantity
47,271 sales units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

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

The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

Code information

Lots 0010-0037

Distribution pattern

Worldwide distribution - US Nationwide distribution.

device · product 2 of 2

VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Z-2771-2020
Recall number
Z-2771-2020
Initiated
July 17, 2020
Classification
Class II
Status
Terminated
Quantity
2349 sales units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

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

The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

Code information

Lots 0010 - 0013

Distribution pattern

Worldwide distribution - US Nationwide distribution.