| Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit | |
Date Initiated by Firm | January 02, 2018 |
Date Posted | May 04, 2018 |
Recall Status1 |
Terminated 3 on February 10, 2023 |
Recall Number | Z-1674-2018 |
Recall Event ID |
79505 |
510(K)Number | K013134 |
Product Classification |
System, test, radioallergosorbent (rast) immunological - Product Code DHB
|
Product | IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit |
Code Information |
3g Allergy specific IgE Universal kit, 3g Allergy specific IgE Universal kit (IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 (D)) Lot codes: 3g Allergy Specific IgE Lot # 461 462 463 464 465 466 467 468 469 470 471 472 473 475 476 3g Allergy Specific IgE Lot # D463 D464 D465 D466 D467 D469 D471 D472 D476 D483 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact | Ms. Aarti M. Aziz 914-631-8000 |
Manufacturer Reason for Recall | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin. |
FDA Determined Cause 2 | Error in labeling |
Action | Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA |
Distribution | Nationwide and Canada, Mexico, and Thailand |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = DHB
|
|
|
|