Recall Z-1843-2015 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jun 25, 2015 (initiated May 6, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 Ef |
| Quantity | 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, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013134 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) Diagnostic Products Corp., Oct 15, 2001 |