RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack).… recallZ-2230-2025 · Siemens Healthcare Diagnostics Inc · initiated Jun 26, 2025

Class II Open, Classified All recalls posted in July 2025

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number: Z-2230-2025
Recall class: Class II
Status: Open, Classified
Initiated by the company: Jun 26, 2025
Posted by the FDA: Jul 31, 2025
Recalling firm: Siemens Healthcare Diagnostics Inc
Quantity: 1,477 units
Product code: CHL
FDA submissions: K002738
Distribution: worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.

Product description

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

Code information (models, lots, serial numbers)

Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

RAPIDPoint® 400/405/500 Wash/Waste Cartridge 10329097
Siemens Healthcare Diagnostics Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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