Siemens ADVIA Centaur Folate Assay Recalled for Potential Out-of-Range Results
Siemens Healthcare Diagnostics is recalling specific lots of the ADVIA Centaur Folate assay because serum controls may go out of range low and whole blood patient results may shift.
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 potential diagnostic errors (out-of-range controls and shifted patient results) which could lead to incorrect medical decisions, but no specific injuries or illnesses are reported in the source text, 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 specific lots of the ADVIA Centaur Folate assay, used for the quantitative determination of folate in serum or red blood cells. The recall affects 49,123 units distributed worldwide, including the United States and numerous countries in Europe, the Middle East, and other regions.
The recall was initiated because serum controls may go out of range low with the ADVIA Centaur Systems Folate assay, and a shift in whole blood patient results may occur. The affected kit lots are identified by specific lot number endings and expiration dates, including lots ending in 219, 222, 224, 225, 226, and 227, with expiration dates ranging from March 2014 to October 2014.
Healthcare facilities and laboratories using these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 49,123
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 (7)
- Kit Lots ending in and exp date: 219 Exp. Date 25 March
- 2014
- 222 Exp Date 12 May
- 224 Exp Date 04 August
- 225 Exp Date 04 August
- 226 Exp Date 12 September
- 227 Exp. Date 06 October
Distribution
Distributed nationwide across the United States.
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