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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73442

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

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Event summary

Timeline bucket
February 09, 2016
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

Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.

Z-1633-2016
Recall number
Z-1633-2016
Initiated
February 09, 2016
Classification
Class II
Status
Terminated
Quantity
394

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.

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

Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.

Code information

Lot # EB6064

Distribution pattern

Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.