ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated prot

FDA device recall Z-0101-2021 · posted 2020-10-13 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

JIT

Quantity affected

US: 23 units; OUS: 204 units

Distribution

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

Date initiated

2020-09-22

Date posted

2020-10-13

Location

Tarrytown, NY

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