—#183848

Product

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 Chemistry systems Siemens Material Number (SMN): 10361941

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K131307
Affected lot / code info: All lots UDI: (01)00630414558073(10)501874(17)20201128 (01)00630414558073(10)514594(17)20210221 (01)00630414558073(10)528971(17)20210630

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.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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¿¿¿¿¿¿¿¿

Timeline

Recall initiated: 2020-09-22
Posted by FDA: 2020-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.