Herpes Simplex Virus I — Class II medical device recall Z-2205-2017
Terminated recall by Cell Marque Corporation, reported 2017-06-07, distributed nationwide. Cell Marque has determined the need to issue a product recall after identifying product intended to be sold ou
| Recall number | Z-2205-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cell Marque Corporation, Rocklin, CA, United States |
| Recall initiated | 2017-05-05 |
| Classified | 2017-06-01 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2017-09-07 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | labeling |
| Lot numbers | 1432301A, 1525206A, 201, 2017-10, 8-08 |
| Model numbers | 361A-18 |
Product
Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Reason for recall
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
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-2205-2017. 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.