Titan Gel Serum Protein Control: SPE Control Cat — Class II medical device recall Z-2434-2019
Terminated recall by Helena Laboratories, Inc., reported 2019-09-11, distributed in FL, IL, MN, MT, NY, OH, TN, TX…. Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of
| Recall number | Z-2434-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Inc., Beaumont, TX, United States |
| Recall initiated | 2016-10-14 |
| Classified | 2019-08-30 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2023-10-12 |
| Distributed | FL, IL, MN, MT, NY, OH, TN, TX, VA, WI |
| Countries outside the US | AU, CA, JO, KR |
| Quantity | 65 kits |
| Reason classes | potency |
| Lot numbers | 1-16-5136, 3-17 |
| Model numbers | 2.0, 5136 |
Product
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Reason for recall
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
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-2434-2019. 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.