Z-1188-2021 Class II Ongoing
FDA device recall Z-1188-2021 was initiated by Siemens Healthcare Diagnostics, Inc. on February 3, 2021 and is designated Class II. Reason for recall: Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (… The recall status is ongoing. Affected quantity: 4174 devices (Domestic: 2836 devices, Foreign: 1338 devices).
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- February 3, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4174 devices (Domestic: 2836 devices, Foreign: 1338 devices)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the countries of Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, SA, Slovakia, Slovenia, Spain, Switzerland.