Date Initiated by Firm | June 29, 2017 |
Create Date | May 04, 2018 |
Recall Status1 |
Terminated 3 on April 23, 2020 |
Recall Number | Z-1661-2018 |
Recall Event ID |
79225 |
510(K)Number | K060385 |
Product Classification |
Enzyme immunoassay, tracrolimus - Product Code MLM
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Product | Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | Mindy Losapio 914-524-2312 |
Manufacturer 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. |
FDA Determined Cause 2 | Device Design |
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. |
Quantity in Commerce | 10,067 |
Distribution | Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MLM
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