FDA Device recall Z-2282-2016
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package
- FDA Device
- Class III
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class III recall of Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package by Tosoh Bioscience, citing instructions For Use had incorrect lot number and calibrator values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2282-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-07 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
Product
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Reason
Instructions For Use had incorrect lot number and calibrator values
Identifiers
| code_info | Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2282-2016%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.