Siemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy
Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.
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: This is a risk-of-harm medical device where the manufacturing defect could produce inaccurate laboratory test results for seven different analytes, potentially impacting patient diagnosis and care. However, no illnesses or injuries have been reported, which per the rubric limits this to High rather than Severe.
Plain-English summary
Siemens Healthcare Diagnostics is recalling approximately 9,729 Atellica CH Reaction Ring Cuvette Segments (Siemens Material Number 11099326) due to a manufacturing defect. The cuvettes are components used in laboratory analyzers to contain and incubate sample reactions.
A manufacturing defect causes these cuvettes to produce inaccurate test results. The devices can output erroneously depressed or elevated results for seven analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate. Inaccurate test results could impact patient diagnosis and clinical decision-making.
The recall applies to all Atellica CH Reaction Ring Cuvette Segments with lot numbers beginning with "N15" on the packaging or "15" on the underside of the segment. These units have been distributed nationwide throughout the United States and internationally.
The recalled product
- Product
- Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 9,729
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 (20)
- N1526424 (01)00630414596143(10)N1526424(17)20291001
- N1525924 (01)00630414596143(10)N1525924(17)20290924
- N1525324 (01)00630414596143(10)N1525324(17)20290918
- N1524224 (01)00630414596143(10)N1524224(17)20290911
- N1523724 (01)00630414596143(10)N1523724(17)20290904
- N1523024 (01)00630414596143(10)N1523024(17)20290827
- N1521824 (01)00630414596143(10)N1521824(17)20290814
- N1521424 (01)00630414596143(10)N1521424(17)20290808
- N1519324 (01)00630414596143(10)N1519324(17)20290719
- N1518924 (01)00630414596143(10)N1518924(17)20290716
- N1518224 (01)00630414596143(10)N1518224(17)20290710
- N1518324 (01)00630414596143(10)N1518324(17)20290710
- N1516224 (01)00630414596143(10)N1516224(17)20290621
- N1515624 (01)00630414596143(10)N1515624(17)20290612
- N1514924 (01)00630414596143(10)N1514924(17)20290605
- N1514124 (01)00630414596143(10)N1514124(17)20290530
- N1513324 (01)00630414596143(10)N1513324(17)20290522
- N1512824 (01)00630414596143(10)N1512824(17)20290515
- N1512424 (01)00630414596143(10)N1512424(17)20290510
- N1511224 (01)00630414596143(10)N1511224(17)20290506
Distribution
Distributed nationwide across the United States.
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