Atellica hemoglobin A1c assay may return depressed patient results
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.
What this means for you
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source states a negative bias may delay diabetes diagnosis or lead to less-than-optimal treatment, and no injuries are stated.
Plain-English summary
Siemens is recalling the Atellica CH Enzymatic Hemoglobin A1c (A1c_E), Siemens Material Number 11097536. About 21,291 units were distributed, 9,750 in the United States and 11,541 outside it, across more than thirty countries. The FDA has classified this recall as Class II.
There is a potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use. When the issue is present, quality control results demonstrate a negative trend and increased imprecision. Siemens states the clinical impact of a negative bias may lead to a delay in diagnosis for diabetes or less-than-optimal treatment for existing diabetes.
Affected product carries UDI-DI 00630414220505, across eighteen listed lot numbers beginning 150131.
Laboratories can identify affected assays by the material number, UDI and lot numbers above, and may contact Siemens for further information.
The recalled product
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (20)
- Siemens Material Number (SMN): 11097536
- UDI-DI: 00630414220505
- Lot numbers: 150131
- 150132
- 150232
- 150260
- 150283
- 150344
- 150361
- 150365
- 150366
- 150445
- 150453
- 150460
- 150498
- 150505
- 150562
- 150600
- 150618
- 150621
Distribution
Distributed nationwide across the United States.
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