Z-1563-2021 Class II Terminated
FDA device recall Z-1563-2021 was initiated by Randox Laboratories Ltd. on March 29, 2021 and is designated Class II. Reason for recall: Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bi… The recall status is terminated (terminated November 22, 2021). Affected quantity: 98 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- March 29, 2021
- Termination Date
- November 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 kits
Product Description
Reason for Recall
Distribution Pattern
Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany, Greece, Hong Kong, Iraq, Italy, Ireland, Jordan, Kazakhstan, Kenya, Lithuania, Luxembourg, Mauritius, Mexico, Myanmar, Nepal, New Zealand, Pakistan, Palestine, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, The Netherlands, Turkey, UK, Ukraine, USA, and Vietnam.