—#163963

Product

ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

FDA product code: CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K991576
Affected lot / code info: Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513

Why it was recalled

Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Date recall was initiated: 03-27-18 Customer communication was sent on 04-03-18 Urgent Medical Device Recall (CHC18-04.A.US) was distributed to all customers in the United States and an Urgent Field Safety Notice (CHC18-04.A.OUS) was distributed to all customers outside the United States who have received ADVIA Chemistry Urea Nitrogen reagent kit lots 408143 and 418290 (Lot 418290 was not sold in the US). These letters instruct the customers to discontinue use of reagent kit lots 408143 and 418290 and to contact their Customer Care Center for replacements kits. In the US the method of distribution is Fed Ex and outside the US the distribution is determined at the country level.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and worldwide

Timeline

Recall initiated: 2018-03-27
Terminated: 2021-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.