Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias
Siemens is recalling specific Calibrator A Kits due to a negative bias in FT4 assays and potential calibration failures on certain systems.
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, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, representing a risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 1,937 units of ADVIA Centaur Systems Calibrator A Kits. The affected lots are identified by lot numbers ending in 90, specifically 07996A90, 21172A90, 27221A90, 44366A90, and 63785A90, with an expiration date of July 24, 2017. The kits were distributed nationwide and to numerous international locations.
The recall was initiated because Siemens confirmed a negative bias for the Free T4 (FT4) assay when using these specific calibrator lots on the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT Systems. Additionally, there is a potential for calibration failures due to above-limit calibrator RLU %CVs when using these lots with the FT4 assay. The performance of the FT4 assay on the ADVIA Centaur CP System is not affected by this issue.
Customers may continue to use the affected Calibrator A kit lots for the FT3, T3, T4, and TUp assays on the ADVIA Centaur Systems. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 1,937
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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