Siemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Realignment Issue
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue with Ferritin Analytical Sensitivity. The recall affects 234 kits distributed worldwide.
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 indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to high-risk products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 234 kits of ADVIA Centaur Calibrator C. This in-vitro diagnostic product is used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system. The recall is due to a realignment issue with the Ferritin Analytical Sensitivity and Calibrator C when used with specific kit lots.
The affected products are identified by lot numbers 83496A22, 88716A22, 95040822, and 95889A22, with an expiration date of 01/19/2013. The recall covers kits distributed nationwide and in numerous countries, including Argentina, Australia, Brazil, Canada, China, and others.
Healthcare facilities and laboratories should stop using the affected calibrator kits and contact Siemens Healthcare Diagnostics for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 234
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 numbers: 83496A22 88716A22 95040822 95889A22 Exp. 01/19/2013
Distribution
Distributed nationwide across the United States.
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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