Terminated

Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall Z-1651-2018 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.

Recall StatusTerminated

Product CodeCIT

Date Initiated2017-06-29

Date Terminated2020-04-23

Product Quantity181,072

Reason for Recall

Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

Firm Action

Letters were sent to consignees with the following instructions: " Please review this letter with your Medical Director. " Venipuncture should occur before drug administration of Sulfasalazine or Sulfapyridine as indicated above under Reason For Correction. Baseline assay values before administration of Sulfasalazine or Sulfapyridine therapy would not be affected. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " If you have received any complaints of illness or adverse events associated with the products listed in Table 1 or 2, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative.

Root Cause

Device Design

Distribution Pattern

Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan Bolivia Albania¿¿¿¿¿¿¿¿ Algeria¿¿¿¿¿¿¿¿ Angola ARGENTINA Armenia AUSTRALIA Austria¿¿¿¿¿¿¿¿ Azerbaijan Bahamas Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belarus¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Bulgaria¿¿¿¿¿¿¿ Cambodia Canada Canary islands Chile China Colombia Costa Rica Croatia¿¿¿¿¿¿¿¿ Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Ecuador Egypt¿¿¿¿¿¿¿¿¿¿ El Salavador Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Guatemala Honduras Hong Kong Hungary¿¿¿¿¿¿¿¿ Iceland India Indonesia Iraq Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ japan Jordan Kazakhstan¿¿¿¿¿ Korea Kuwait Latvia¿¿¿¿¿¿¿¿¿ Lebanon Lithuania¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Macedonia Malaysia Mali Malta¿¿¿¿¿¿¿¿¿¿ Mexico Morocco¿¿¿¿¿¿¿¿ Myanmar Nepal Netherlands¿¿¿¿ New Zealand Nicaragua Norway¿¿¿¿¿¿¿¿¿ Oman Pakistan¿¿¿¿¿¿¿ Paraguay Peru Philippines Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Saudi Arabia Senegal Serbia¿¿¿¿¿¿¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ South Africa South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tajikistan Thailand Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ Turkmenistan¿¿¿ United Arab Emerites¿¿¿¿¿¿ United¿Kingdom¿ Uruguay¿¿¿¿¿¿¿¿ Uzbekistan Vatikancity¿¿¿¿ Venezuela Vietnam Yemen

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare Diagnostics · 2011-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.