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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76251

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

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Event summary

Timeline bucket
January 11, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare 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

N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Z-1227-2017
Recall number
Z-1227-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
US: 62 kits; Foreign: 290 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.

Code information

Lot 802907632, Exp. 2017-02-13

Distribution pattern

Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.