Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Summary
The FDA issued a Class II for Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 by Siemens Healthcare Diagnostics, Inc.. Reason: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator .
Details
Source
Device Recall
External ID
Z-0930-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Lot/Code Info: UDI: 00630414595580; Lot Numbers: 211359 211451
Quantity Affected: 199
Reason for Recall
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Distribution
Global Distribution. US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-09
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0930-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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