Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Reported: April 20, 2022 Initiated: February 9, 2022 #Z-0930-2022
Product Description
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Reason for Recall
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 199
- Distribution
- Global Distribution. US Nationwide.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 199.
Why was this product recalled? ▼
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0930-2022.
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