Instructions for Use — Class III medical device recall Z-2282-2016
Terminated recall by Tosoh Bioscience, Inc., reported 2016-08-03, distributed nationwide. Instructions For Use had incorrect lot number and calibrator values
| Recall number | Z-2282-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience, Inc., South San Francisco, CA, United States |
| Recall initiated | 2016-06-07 |
| Classified | 2016-07-25 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-02-22 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | G13C303 |
| Model numbers | 02534001 |
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 for recall
Instructions For Use had incorrect lot number and calibrator values
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2282-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.