Siemens ADVIA Centaur HCY Diluent Recalled for Inaccurate Dilution Recovery
Siemens Healthcare Diagnostics is recalling ADVIA Centaur HCY Diluent because dilution recovery was lower than reported in the instructions for use.
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 test results due to dilution recovery issues, which is a moderate risk without reported injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 51 units of ADVIA Centaur HCY Diluent, 10mL Bottle (Catalog number 09877493, SMN 10310370) and Ancillary Pack (Catalog number 03302138, SMN 10378677). The affected lots are 88D1524 (expiration date 01 Jun 2014) and 88D3303 (expiration date 26 Nov 2013). The product is used on the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur CP platforms for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
The recall was initiated because the homocysteine dilution recovery on the diluent identified percent recovery for 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU). This discrepancy may affect the accuracy of test results.
The product was distributed worldwide, including the United States (nationwide) and numerous countries in Europe, the Middle East, and Asia. Users of the affected lots should stop using the product and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 51
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 (1)
- Lot #/Exp. Date: 88D1524 01 Jun 2014 88D3303 26 Nov 2013
Distribution
Distributed nationwide across the United States.
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