Siemens ADVIA Centaur Intact PTH Calibrator Recalled for Packaging Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Intact PTH Calibrators because some kits were packaged with only the high calibrator.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a packaging error affecting a small number of kits, fitting the criteria for a Low severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 595 kits of the ADVIA Centaur Intact PTH Calibrator (6 pack), Catalog Number SMN 10492387. The recall is due to a packaging error where 5 of the kits were found to contain only the high calibrator, rather than the full set of calibrators required for proper assay calibration.
The affected product is intended for in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems. The specific lot number is 14136A16, with a date of 04 Mar 2014. The product was distributed nationwide, including in Maryland, Pennsylvania, and Connecticut.
Healthcare facilities and users of the ADVIA Centaur Systems should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for instructions on return or replacement. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
- 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 (1)
- Kit Lot: 14136A16 04 Mar 2014
Distribution
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