Recall Z-1268-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1268-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-27

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2023-01-27. It names one FDA 510(k) clearance: K982529. Product: Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632. Reason: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-27
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K982529 — RANDOX DIRECT LDL CHOLESTEROLRandox Laboratories, Ltd.·cleared 1998-09-11

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 CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632

Reason for recall

Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

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