Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
See all recalls from Siemens Healthcare Diagnostics, Inc. →Recalled Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Hazard / Issue
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: All Lots within expiry/UDI: 00630414611099
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Atellica CH Urine Albumin →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime