Z-1659-2016Class II

Dimension Assays: Direct HDL Cholesterol (AHDL)

Name: Z-1659-2016 Dimension Assays: Direct HDL Cholesterol (AHDL)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-03-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-03-17 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Assays: Direct HDL Cholesterol (AHDL) on 2016-03-17. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1659-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-17
Posted: 2016-05-11
Terminated: 2017-09-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Assays: Direct HDL Cholesterol (AHDL)
Product code: JHM Colorimetric Method, Lipoproteins
Reason for recall: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
Root cause tag: design
FDA root cause: Device Design
Action: Siemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the letter with their Medical Director and ensure Venipuncture occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be affected. Customers were asked to complete and return the Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.
Quantity in commerce: 137422 units total
Distribution: Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands
Product codes and lots: Device Listing: D 044702 - Direct HDL Cholesterol (AHDL), Catalog # DF48B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1659-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1651-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1652-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1653-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1654-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1655-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1656-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1657-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1658-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1659-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1660-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1661-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1662-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1663-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1664-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1665-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1666-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11

Product code JHM

K073072Class IDimension Ahdl Flex Reagent Cartridge, Model: Df48bDade Behring, Inc. / cleared 2008-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)