Recall Z-1816-2022— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1816-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-17

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-08-17. It names one FDA 510(k) clearance: K861700. Product: Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57. Reason: Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-17
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K861700 — DIMENSION (TM) CLINICAL CHEMISTRY SYSTEME.I. Dupont DE Nemours & Co., Inc.·cleared 1986-06-11

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

Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57

Reason for recall

Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

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