Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic… recallZ-3169-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 15, 2024

Why it was recalled

Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Siemens Healthcare issued Urgent Medical Device Corrections (UMDC) to US consignees ACHC24-05.A.US, ACHC24-05.A.US.CHC on 8/15/24 via FedX and Urgent Field Safety Notices (UFSN)to foreign consignees ACHC24-05.A.OUS, ACHC24-05.A.OUS.CHC to affected customers informing them of the issue and the impact to results. ADVIA Chemistry customers are advised that lot 665399 meets the IFU prozone claim. Customers will be instructed to discontinue use of and discard the impacted reagent lots indicated in the letter. Atellica CH customers will be advised that lots 242194, 242195, and 242321 meet the IFU prozone claim. Customers can continue to use the impacted products, with the understanding that patient samples with values above 9,500 mg/dL (95,000 mg/L) can result in falsely depressed results when using the impacted lots. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution Lot 665399 meets the IFU prozone effect claim. The manufacturing control system has been updated to ensure that there is no impact to future lots. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Recall details

Recall number

Z-3169-2024

Status

Open, Classified

Initiated by the company

Aug 15, 2024

Posted by the FDA

Sep 18, 2024

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Quantity

18483 units

Product code

JIR

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Canada, Chile, Colombia, Croatia, Cura¿ao, St. Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong¿Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Mexico, Morocco, Netherlands, New¿Zealand, Norway, Oman, P.R.¿China, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Republic¿Korea, Romania, Russian¿Fed., Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, United¿Kingdom, Uruguay, Vietnam, Zaire. ¿¿¿¿¿¿

Product description

Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Atellica CH uALB_2 11097610

  Siemens Healthcare Diagnostics Inc. · INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
  1 recall3 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 95218).

• Z-3170-2024 · Open, Classified
  ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atell…