Atellica CH Systems Fructosamine (FRUC)-For in vitro… recallZ-0102-2021 · Siemens Healthcare Diagnostics, Inc. · initiated Sep 22, 2020

Why it was recalled

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

FDA root cause category: Device Design

What the company is doing

Siemens Urgent Medical Device Recall (ACHC20-18.A.US.CHC) distributed to customers on 9/22/20, in the United States and an Urgent Field Safety Notice (ACHC20-18.A.OUS.CHC) was distributed to customers outside the United States who have received ADVIA Chemistry Fructosamine in-date reagent lots. For Atellica, an Urgent Medical Device Recall (ACHC20-18.A.US) was distributed to l customers in the United States and an Urgent Field Safety Notice (ACHC20-1.OUS) was distributed to all customers outside the United States who have received Atellica CH in date reagent lots. These letters instruct the customers to: Perform the following actions on the ADVIA Chemistry System 1. Enter the Real-time correction factor in the Analytical Parameters (Chemistry) window. 2. Once the Real-time correction factor has been configured, update QC ranges as described above in the FRUC QC Definition following your laboratory procedures. 3. Update the reference range following your laboratory procedures. 4. Perform a FRUC calibration and process QC. 5. Perform a system back-up. Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. " Review this letter with your Medical Director. " If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative

Recall details

Recall number

Z-0102-2021

Status

Open, Classified

Initiated by the company

Sep 22, 2020

Posted by the FDA

Oct 13, 2020

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Quantity

US: 28; OUS: 255 units

Product code

JIT

FDA submissions

K131307

Distribution

CA, DE, MD, NC, NJ, NY, PA Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Brazil¿¿¿¿ Canada¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vietnam¿¿¿¿¿¿¿¿

Product description

Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

Devices named in this recall

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

• Atellica CH Fruc 11097637

  Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN
  2 recalls0 reports

Other devices under the same FDA submission

1 device cleared under K131307 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ADVIA® Chemistry FRUC Reagents 10361941

  Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 86504).

• Z-0101-2021 · Open, Classified
  ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Che…