Siemens Atellica CH Chemistry Calibrator Recalled for Calibration Errors
Siemens Healthcare Diagnostics is recalling Atellica CH Chemistry Calibrators due to observed calibration errors in Total and Direct Bilirubin assays.
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 FDA classified this as a Class II recall. The source text describes calibration errors but does not report any specific patient injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall involving potential diagnostic inaccuracies.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,522 units of Atellica CH Chemistry Calibrator. The recall affects lots 534179 (including sublots A, B, C, D, and E) and 911591 (including sublots A, B, and C). These products were distributed nationwide in the United States.
The recall was initiated because calibration errors were observed with the Total and Direct Bilirubin assays when using the affected Chemistry Calibrator lots. The source text notes that similar errors were observed with lot 534177 for ADVIA Chemistry, but the current recall specifically targets the Atellica CH lots listed above.
Healthcare facilities and laboratories should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Atellica CH Chemistry Calibrator
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,522
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 (4)
- 534179 (including sublots A
- B
- C
- D and E) 911591 (including sublots A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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