Siemens Healthcare Diagnostics, Inc Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)9 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.

Recommended Action

Per FDA guidance

All affected customers were sent a letter on 08/25/2020 stating the following: Siemens Healthcare Diagnostics Inc. (Siemens Healthineers) notified customers on August 25th, 2020. Letter states reason for recall, health risk and action to take. Actions to be taken by their customers include: - Reviewing the letter with their Medical Director. - Customers may continue use of the product lots referenced in Table 1 until they receive replacement product in their laboratory. Refer to the Table 3 for product biasinformation. - If you are currently using the products listed in Table1, review your inventory of these products, as well as the associated product QC and MCM, and order replacement products by completing the Field Correction Effectiveness Check Form attached to the letter. - Upon acceptance of the replacement lots referenced in Table 2 New Lot Combinations column, discontinue use of and discard the products listed in Table 2 Current Lot Combinations column. Refer to Figures 1 through 4 for expected results with replacement lots. - Complete and return the Field Correction Effectiveness Check Form attached to this letter. Retain the letter with your laboratory records and forward the letter to those who may have received this product.