Recall Z-2230-2025 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
| Date | Jul 31, 2025 (initiated Jun 26, 2025) |
| Status | Open, Classified |
| Reason | Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not cau |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare sent an Urgent Medical Device Correction (UMDC) letter to consignees (via FedEx in the US) on around 06/26/2025. The communication letter informs consignees of the issue and provided actions for consignees to take. Consignees were instructed to review the letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, replace the both the measurement cartridge and the wash/waste cartridge if still using a wash/waste cartridge from lot WW/08925 with RAPIDPoint systems, discontinue use of the wash/ |
| Quantity | 1,477 units |
| Distribution | worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002738 | BAYER RAPIDPOINT 400 SYSTEM Bayer Corp., Dec 19, 2000 |