Recall Z-1150-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1150-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-09

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2023-01-09. It names one FDA 510(k) clearance: K172201. Product: Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573. Reason: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-09
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K172201 — Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.·cleared 2018-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

Reason for recall

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Data sourced from openFDA. This site is unofficial and independent of the FDA.