Recall Z-1980-2026 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Siemens Healthcare Diagnostics, Inc.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
| Date | Apr 28, 2026 (initiated Mar 18, 2026) |
| Status | Open, Classified |
| 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132638 | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics, Inc., Jan 27, 2014 |