Recall Z-1980-2026— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1980-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-18

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2026-03-18. It names one FDA 510(k) clearance: K132638. Product: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.. Reason: Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-03-18
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics, Inc.·cleared 2014-01-27

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 Creatinine Flex reagent cartridge. Material Number: 10872079.

Reason for recall

Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results

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