Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues
Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.
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: This is an FDA Class II recall involving potential reagent carryover in a diagnostic test reagent kit. While no illnesses or injuries are reported in the source, inaccurate hemoglobin A1c results could lead to improper diabetes management and represent a risk of harm to patients.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H) reagent kit (Material Number 11097536). A total of 6,606 units have been distributed globally, including throughout the United States. The affected lot numbers are: 110027, 110060, 110065, 110091, 110113, 110129, 110137, 110161, 110170, 110208, 110224, 110234, 110235, 110262, 110265, 110273, 110286, 110315, 110330, 110347, and 110360.
Siemens Healthcare has identified a potential issue with reagent carryover in these kits. Reagent carryover can affect the accuracy of quality control results, patient test samples, and calibrator results. Hemoglobin A1c measurements are used to assess long-term blood glucose control in diabetes patients. Inaccurate results could lead to improper diabetes management decisions.
Clinical laboratories and healthcare facilities currently using these reagent kits should immediately discontinue use of the affected lot numbers. Facilities should contact Siemens Healthcare Diagnostics for instructions on returning affected kits and obtaining replacement reagents. Consider reviewing any test results obtained using these specific lot numbers, particularly for critical patient care decisions.
The recalled product
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 6,606
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)
- UDI: 00630414220505
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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