Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RAPIDPoint 500 Systems Wash/Waste Cartridge

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall RAPIDPoint 500 Systems Wash/Waste Cartridgesee related information
Date Initiated by FirmJune 26, 2025
Date PostedJuly 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2230-2025
Recall Event ID 97209
510(K)NumberK002738 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
ProductRAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Code Information Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.
FEI Number 3002637618
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information ContactCustomer Service USA
877-229-3711
Manufacturer Reason
for Recall		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 caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
FDA Determined
Cause 2		Under Investigation by firm
ActionSiemens 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/waste cartridges from lot WW/08925 and dispose any remaining inventory in possession. No-cost replacement wash/waste cartridges should be made through the local Siemens Healthineers or distributor office. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form included with letter, notify customers if products were further distributed, and to retain this letter with your laboratory records and forward this letter to those who may have received this product at your site.
Quantity in Commerce1,477 units
Distributionworldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CHL
-
-