Z-2230-2025Class II

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097

Name: Z-2230-2025 RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097
Creator: Siemens Healthcare Diagnostics Inc
Published: 2025-06-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-06-26 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc began a recall of RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097 on 2025-06-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2230-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-26
Posted: 2025-07-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: manufacturing process
FDA 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/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 commerce: 1,477 units
Distribution: worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
Product codes and lots: Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2230-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2230-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31

Product code CHL

K002738Class IIBayer Rapidpoint 400 SystemBayer Corp. / cleared 2000-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)