Siemens Calibrator E Recalled for Positive Bias in Cortisol and Progesterone Assays
Siemens Healthcare Diagnostics is recalling Calibrator E kits due to positive bias in Cortisol and Progesterone assays on ADVIA Centaur Systems.
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of Siemens Calibrator E kits. The affected products include SMN 10309079 (2 pack), SMN 10321075 (6 pack), and SMN 10335532 (6 pack Ref). The total quantity involved is 19,352 units.
The recall is due to a positive bias observed in the Calibrator E lot kits when used with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves. This bias affects kits with lot numbers ending in 38 and 39.
The affected products were distributed nationwide, including Puerto Rico, and worldwide to numerous countries. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
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)
- 26284A38
- 26900A38
- 27991A38
- 28192A38
- 29571A38
- 31162A38
- 32488A38
- 35243AB39
- 35295AB39
- 36091AB39
- 39464AB39
- 40245AB39
- 41317AB39
- 26285A38
- 27348A38
- 29169A38
- 30710A38
- 31261A38
- 32687A38
- 35259AB39
Distribution
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