FDA Device recall Z-1363-2019
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to…
- FDA Device
- Class III
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class III recall of Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to… by Abbott Laboratories, citing devices were delivered without the required dry ice.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1363-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-09 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | n/a |
Product
Technopath Multichem S Plus Level 2 - 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
Devices were delivered without the required dry ice.
Identifiers
| code_info | LN 5P78-11; Lot 18005182 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1363-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.