The Recall Desk
ModerateFDA (Devices)·Z-0930-2022·Announced 2022-04-20

Siemens Atellica CH Fructosamine Reagent Recalled for Potential Carryover

Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II medical device with potential for reagent carryover affecting diagnostic test accuracy. No reported illnesses or injuries have been documented. The hazard is stated as potential rather than confirmed realized harm, placing this at Moderate severity.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Fructosamine (Fruc) diagnostic reagent due to potential reagent carryover. The affected lot numbers are 211359 and 211451. This issue could impact the accuracy of quality control (QC) testing, patient sample results, and calibrator results. A total of 199 units were distributed globally, including throughout the United States.

The recalled product

Product
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
  • reagent-carryover
  • diagnostic-inaccuracy

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 (2)

  • UDI: 00630414595580
  • Lot Numbers: 211359 211451

Distribution

Distributed nationwide across the United States.

Related recalls

Same category