Z-1382-2019 Class I Terminated
FDA device recall Z-1382-2019 was initiated by Beckman Coulter Inc. on July 30, 2018 and is designated Class I. Reason for recall: Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. The recall status is terminated (terminated March 31, 2022). Affected quantity: 5,414 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- July 30, 2018
- Termination Date
- March 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,414 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lithuania, Mexico, Morocco, Myanmar, Netherlands Antilles, New Zealand, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Trinidad and Tobago, U.A.E, United Kingdom, and Vietnam.