Siemens RapidLab 1245 System Recalled for Neonatal Bilirubin Variability
Siemens is recalling 241 RapidLab 1245 systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves increased variability in a diagnostic parameter rather than a direct physical injury or acute illness, fitting the criteria for a moderate severity rating.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 241 units of the RAPIDLab 1245 System. The recall covers devices with Siemens Material Numbers 10321844, 10491393, and 10337179. These in vitro diagnostic systems are intended for use by healthcare professionals to quantitatively test human whole blood.
The recall is due to a potential issue where the neonatal bilirubin (nBili) parameter may exhibit increased variability. This specific condition occurs when the nBili concentration is greater than 12 mg/dl and the total hemoglobin (tHb) concentration exceeds the upper reportable range of greater than 25 g/dl.
The affected devices were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous countries across Europe, Asia, Africa, and South America. All serial numbers are included in this recall. Healthcare professionals should contact Siemens Healthcare Diagnostics Inc for further instructions on how to proceed with the affected devices.
The recalled product
- Product
- RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 241
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 (1)
- All serial numbers.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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