Z-1670-2021 Class II Terminated
FDA device recall Z-1670-2021 was initiated by Beckman Coulter Inc. on April 14, 2021 and is designated Class II. Reason for recall: specimens collected in transport media may result is false negative results when stored in certain conditions. The recall status is terminated (terminated May 19, 2023). Affected quantity: 1,034 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- April 14, 2021
- Termination Date
- May 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,034 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia and the country of New Zealand.