Siemens RAPIDLab 1265 System Recalled for Neonatal Bilirubin Variability
Siemens Healthcare Diagnostics Inc is recalling 2,863 RAPIDLab 1265 Systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.
What this means for you
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, but the source text describes a potential for increased variability in a specific parameter under specific conditions without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 2,863 RAPIDLab 1265 Systems, identified by Siemens Material Numbers 10491395, 10321852, and 10335524. These in vitro diagnostic systems are intended for quantitative testing of human whole blood by healthcare professionals. The recall covers all serial numbers for these specific material numbers.
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 FDA has classified this as a Class II recall.
The affected devices were distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, Mexico, and numerous other countries across Europe, Asia, Africa, and the Americas. Healthcare professionals using these systems should be aware of this potential variability in neonatal bilirubin results under the specified conditions.
The recalled product
- Product
- RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. 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: RA
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 2,863
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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