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IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE… recallZ-1674-2018 · Siemens Healthcare Diagnostics, Inc. · initiated Jan 2, 2018

Class II Terminated All recalls posted in May 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number
Z-1674-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 2, 2018
Posted by the FDA
May 4, 2018
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Product code
DHB
FDA submissions
K013134
Distribution
Nationwide and Canada, Mexico, and Thailand

Product description

IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

3 devices cleared under K013134 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 79505).

Sources and updates

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