The Recall Desk
HighFDA (Devices)·Z-2214-2024·Announced 2024-07-03

RAPIDPoint 500e diagnostic system mislabels capillary blood samples as arterial

Siemens RAPIDPoint 500e software version 5.3 incorrectly labels capillary blood samples as arterial on laboratory information system displays, potentially leading to misinterpretation of results and diagnostic errors.

What this means for you

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: This is an FDA Class II recall with no reported illnesses or injuries. However, the hazard presents significant risk of harm: capillary blood samples are misidentified as arterial in the laboratory information system, potentially causing clinicians to misinterpret results and make incorrect treatment decisions. This meets the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics Inc is recalling software version 5.3 for the RAPIDPoint 500e Blood Gas System. This software version contains an issue that affects how sample sources are identified in the laboratory information system (LIS). Specifically, capillary blood samples run in capillary mode are incorrectly labeled as arterial samples on the LIS display.

When capillary samples are analyzed under this software version, they are correctly identified as capillary on both the RAPIDPoint 500e system display and instrument printouts. However, on the laboratory information system, these same samples are incorrectly shown as arterial. This misidentification could cause capillary results to be flagged according to arterial reference ranges, potentially leading to misinterpretation of test results.

Nine units are affected in the United States, with distribution in Florida, Georgia, Louisiana, Michigan, and North Carolina, as well as international distribution to Chile, Costa Rica, France, Germany, Japan, Lebanon, Mexico, Netherlands, New Zealand, Poland, Spain, Turkey, and the United Kingdom. The inability to distinguish specimen sources for blood gas analysis may lead to incorrect diagnoses and management decisions.

The recalled product

Product
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
Manufacturer
Siemens Healthcare Diagnostics Inc
Category
Medical Device — Diagnostic System
Hazard
  • specimen-misidentification
  • diagnostic-error
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI-DI: (1)RAPIDPoint 500e Blood Gas System (USA) 00630414286143
  • (2)RAPIDPoint 500e Blood Gas System (China) 00630414286150
  • (3) RAPIDPoint 500e Blood Gas System (Japan) 00630414286167

Distribution

Distributed nationwide across the United States.

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