Z-1383-2019 Class I Terminated
FDA device recall Z-1383-2019 was initiated by Beckman Coulter Inc. on Jul 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 Mar 31, 2022). Affected quantity: 2,059 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- Jul 30, 2018
- Termination Date
- Mar 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,059 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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1383-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026