Siemens Atellica IM CKMB Calibrator Recalled for Potential Bias
Siemens Healthcare Diagnostics is recalling 97 kits of Atellica IM CKMB Calibrator due to a potential bias compared to internal standards.
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 and involves a risk-of-harm product (medical diagnostic device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 97 kits of the Atellica IM CKMB Calibrator, Catalog Number 10995532. The product is intended for in vitro diagnostic use to evaluate the ADVIA Centaur CKMB assay. The recall is being conducted because a potential bias was identified with certain kits when compared to internal standards.
The affected product was distributed nationwide in the United States. The specific lots involved are 57837A66 and 67443A66, both with an expiration date of December 11, 2018. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and laboratories should stop using the affected calibrator kits and contact Siemens Healthcare Diagnostics for further instructions or a replacement. Consumers should not use this product for home testing, as it is intended for professional in vitro diagnostic use.
The recalled product
- Product
- Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 97
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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