Siemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias
Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.
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. The hazard involves a bias in test results rather than a direct physical injury or acute health threat, fitting the criteria for a moderate severity recall involving potential adverse health consequences through misdiagnosis or treatment errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,719 units of the ADVIA Centaur Systems Progesterone Kit (5-pack Ref). The affected products are identified by Catalog number 02177364 and SMN 10333111. The recall covers specific lot numbers ending in 268 (42590268, 43742268, 44847268) 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 device is used for medical testing, and the bias could affect the accuracy of high-range progesterone measurements.
The affected kits were distributed worldwide, including in the United States and numerous international locations such as Austria, Brazil, Canada, Germany, Japan, and the United Kingdom. Users of these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 1,719
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: 42590268 43742268 44847268 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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