Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64463

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2013
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

Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.

Z-1049-2013
Recall number
Z-1049-2013
Initiated
February 22, 2013
Classification
Class II
Status
Terminated
Quantity
60,674

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.

Code information

Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14.

Distribution pattern

Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

Field note

Send feedback

We'll only use this to respond to your feedback.