Siemens ADVIA Centaur Calibrator A Recalled for T4 Assay Inaccuracy
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator A lots due to under-recovery in the Total T4 assay, which may affect calibration accuracy.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of ADVIA Centaur Calibrator A. The recall involves 265 six-packs of the product, distributed worldwide and nationwide in the United States, including Puerto Rico and numerous states, as well as in several international countries.
The recall is being conducted because Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. This product is used for calibrating various assays, including FT3, T3, T4, Tup, FT4, and THEO2, on ADVIA Centaur or ACS:180 systems. The affected lot numbers are 89983A77, 90669A77, and 90705A77, all with a date of 16 Jul 2013.
Healthcare facilities and users of these systems should stop using the affected lots of Calibrator A and contact Siemens Healthcare Diagnostics for further instructions or replacement. This recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
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 (4)
- REF 10285904 (6 pack): 89983A77 16 Jul 2013
- 90669A77 16 Jul 2013
- REF 10285905 (6 pack - REF)
- 90705A77 16 Jul 2013
Distribution
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