Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Summary
The FDA issued a Class II for Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 by Siemens Healthcare Diagnostics, Inc.. Reason: The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E a.
Details
Source
Device Recall
External ID
Z-0180-2022
Action Date
2021-11-03
Status
Ongoing
Category
device
Product Description
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Lot/Code Info: All lots impacted
Quantity Affected: 1402 (US); 2941 (OUS)
Reason for Recall
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Distribution
Worldwide distribution - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-20
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 124 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-0180-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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