FDA Device recall Z-2434-2019
Titan Gel Serum Protein Control: SPE Control Cat
- FDA Device
- Class II
- terminated
- Published 2019-09-11
On 2019-09-11 the FDA classified a Class II recall of Titan Gel Serum Protein Control: SPE Control Cat by Helena Laboratories, citing due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2434-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-14 |
| Published | 2019-09-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Helena Laboratories |
| Distribution | FL, IL, MN, MT, NY, OH, TN, TX, VA, WI |
Product
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Reason
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Identifiers
| code_info | Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Helena Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2434-2019%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.