AIA-PACK TgAb CONTROL SET — Class III medical device recall Z-2169-2017
Terminated recall by Tosoh Bioscience, Inc., reported 2017-06-07, distributed in AK, FL, GA, MA, NY, OH, OK, TX. The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) a
| Recall number | Z-2169-2017 |
|---|---|
| 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 | 2017-02-08 |
| Classified | 2017-05-26 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2019-02-08 |
| Distributed | AK, FL, GA, MA, NY, OH, OK, TX |
| Quantity | 64 boxes |
| Reason classes | labeling |
| Expiration dates | 2017-06-20, 2017-08-20, 2017-09-30 |
Product
AIA-PACK TgAb CONTROL SET
Reason for recall
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
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-2169-2017. 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.