Siemens ADVIA Centaur Progesterone Kit Recall for High Bias in Results
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL may show high bias.
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. The hazard involves inaccurate diagnostic results (high bias) rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 9,778 units of the ADVIA Centaur Systems Progesterone Kit (Catalog number: 02382928; SMN: 10310305). The affected lots are 42564268, 42621268, and 43834268, all with an expiration date of May 22, 2015.
The recall was initiated because the kits have a high bias on results greater than 30 ng/mL (95.4 nmol/L). This in vitro diagnostic product was distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 9,778
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 (2)
- Lot Numbers: 42564268 42621268 43834268 Exp. Date: May 22
- 2015
Distribution
Part of a larger recall action
This product is one of 3 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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