Siemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results
Siemens is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.
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: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results (high bias) which poses a risk of harm through misdiagnosis, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 11,980 ADVIA Centaur Systems Progesterone Kits (5-pack) due to high bias in test results greater than 30 ng/mL (95.4 nmol/L). The affected product is an in vitro diagnostic kit with catalog number 01586287 and SMN 10315522.
The recall includes specific lot numbers ending in 268 (42565268, 42624268, 43538268) with an expiration date of May 22, 2015. These kits were distributed nationwide in the United States and in numerous countries worldwide, including Austria, Brazil, Canada, Germany, Japan, and the United Kingdom.
This is an FDA Class II recall. The source text does not report any illnesses or injuries associated with the use of these kits. Users should check their inventory for the affected lot numbers and contact Siemens Healthcare Diagnostics for instructions on returning the product.
The recalled product
- Product
- ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 11,980
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: 42565268 42624268 43538268 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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