ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the qua

FDA device recall Z-2451-2023 · posted 2023-08-24 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

Action taken

An Urgent Medical Device Correction dated 7/25/23 was sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Perform the instructions provided in Additional Information. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JIT

Quantity affected

3067 units

Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distribution.

Date initiated

2023-07-25

Date posted

2023-08-24

Location

Tarrytown, NY