Z-1362-2019 Class III Terminated
FDA device recall Z-1362-2019 was initiated by Abbott Laboratories on April 9, 2019 and is designated Class III. Reason for recall: Devices were delivered without the required dry ice. The recall status is terminated (terminated December 20, 2019). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- April 9, 2019
- Termination Date
- December 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Reason for Recall
Devices were delivered without the required dry ice.
Distribution Pattern
Distribution to Latvia.
Code Information
LN 5P78-10; Lot 18004181