RecallRadar

FDA Device recall Z-1843-2015

IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in…

On 2015-07-01 the FDA classified a Class II recall of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in… by Siemens Healthcare Diagnostics, citing IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicate….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1843-2015
ClassificationClass II
Statusterminated
Initiated2015-05-06
Published2015-07-01
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionFL, NM, NY

Product

IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

Reason

IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.

Identifiers

code_infoKit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1843-2015%22

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