RAPIDPoint 500 wash waste cartridge lot biases seven blood analytes
A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a manufacturing error that biases seven blood analyte results, with no patient harm reported in the source.
Plain-English summary
The RAPIDPoint 500 Systems Wash/Waste Cartridge, 4 pack, material number 10329097, GTIN 00630414482163, is being recalled. The action covers 1,477 units from lot WW/08925.
According to Siemens Healthcare Diagnostics, the lot is being recalled due to a manufacturing error causing positive and negative bias in ionized calcium, potassium, pH, chloride, pCO2, glucose and lactate analytes and their derivatives. The notice states that four complaints were filed related to this event. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was worldwide, including nationwide in the United States and to Canada, Chile and Japan among other countries.
Laboratories should identify affected stock using the material number, GTIN and lot number above and follow the instructions issued by Siemens.
The recalled product
- Product
- RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 1,477
Distribution
Distributed nationwide across the United States.
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