IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 103

FDA device recall Z-1843-2015 · posted 2015-06-25 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

Siemens Healthcare Diagnostics issued an Urgent Medical Device Recall Letter (IMC-15-11A.US, dated May 6, 2015) in the US via FedEx, and an Urgent Field Safety Notice (IMC-15-11A.OUS, May 2015) outside the US on May 6, 2015. Customers were instructed to immediately discontinue use of and discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Discontinue use and discard lot 208 after June 30, 2015. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days in the US and OUS and fax to Customer Care Center at 312-275-7795.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DHB

Quantity affected

Domestic: 17 kits, Foreign: 1549 kits

Distribution

Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guate

Date initiated

2015-05-06

Date posted

2015-06-25

Date terminated

2016-06-22

Location

Tarrytown, NY

Related 510(k) clearances