Z-1489-2021 Class II Terminated
FDA device recall Z-1489-2021 was initiated by Ortho-Clinical Diagnostics, INc. on March 26, 2021 and is designated Class II. Reason for recall: Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpe… The recall status is terminated (terminated May 24, 2023). Affected quantity: 865 units of 25 slides each.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 26, 2021
- Termination Date
- May 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 865 units of 25 slides each
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV, WY and the countries of Australia, Bermuda, Brazil, Canada, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.