CLASS II Device recall · Reported 18 May 2016 · FDA Enforcement Report
Dimension Vista Assays: Direct HDL Cholesterol (AHDL) recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista Assays: Direct HDL Cholesterol (AHDL), distributed nationwide in the US. The recall was initiated on 17 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1663-2016
- FDA event ID
- 73667
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2016
- FDA classified
- 11 May 2016
- Reported
- 18 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Mar 2016 | Recall initiated by company | |
| 11 May 2016 | Classified by FDA | +55 days |
| 18 May 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Where it was distributed
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
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Device Listing: D056475 Direct HDL Cholesterol (TRIG) Catalog # K3048A
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 73667This product is part of a recall event; the main page for the event is Dimension Assays: Triglycerides (TGL) recalled.
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