Siemens Healthcare Diagnostics, Inc. 2023-08-30 Health serious FDA
Health · FDA · Recall #FDA-Z-2451-2023
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in… Recall
Issued August 30, 2023 · Siemens Healthcare Diagnostics, Inc.
In August 2023, Siemens Healthcare Diagnostics, Inc. recalled the ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
What you should do
- 1 Stop using ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Healthcare Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Siemens Healthcare Diagnostics, Inc.
- Category
- Health
- Recall date
- August 30, 2023
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distr
- Recall number
- FDA-Z-2451-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Healthcare Diagnostics, Inc. has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.