Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

FDA device recall Z-1980-2026 · posted 2026-04-28 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Action taken

Siemens Healthineers notified consignees on about 03/18/2026 via letter. Consignees were notified of the issue, the hazard involved and instructed to immediately discontinue use of and discard the affected kit lots, each facility should review the recall notification with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, and review inventory to determine the laboratory's replacement needs and communicate that with Siemens Healthineers. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form provided and retain the letter with laboratory records and forward it to anyone how may have received or used the affected product.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CGX

Quantity affected

18,080 units

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, Germany, Honduras, Ind

Date initiated

2026-03-18

Date posted

2026-04-28

Location

Newark, DE

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