Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64874

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

Open FDA event record

Event summary

Timeline bucket
April 01, 2013
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-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

Z-1556-2013
Recall number
Z-1556-2013
Initiated
April 01, 2013
Classification
Class II
Status
Terminated
Quantity
478 total (339- Domestic) (139- International)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling the specific lot due to lower than expected results.

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 firm is recalling the specific lot due to lower than expected results.

Code information

Lot # 1529-17-2636, expiration date 12 June 2013

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.