FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
- Recall number
- Z-1980-2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
- Status
- Open, Classified
- Initiated
- 2026-03-18
- Posted
- 2026-04-28
- Terminated
- not on file
- 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
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 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, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, U.A.E., Ukraine, Uruguay, Vietnam, Yemen.
- Lot, serial or model codes
- Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.
- 510(k) numbers
- ["K132638"]
- PMA numbers
- not on file
- Product code
- CGX
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28