Z-2434-2019Class II

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

Name: Z-2434-2019 Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Creator: Helena Laboratories, Inc.
Published: 2016-10-14
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2016-10-14 / Terminated / root cause: manufacturing process

FDA source

Helena Laboratories, Inc. began a recall of Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL on 2016-10-14. FDA classified it as Class II and gives the reason as "Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2434-2019
Classification: Class II
Status: Terminated
Initiated: 2016-10-14
Posted: 2019-08-30
Terminated: 2023-10-12
Recalling firm: Helena Laboratories, Corp.
Product: Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Between 10/14/2016 to 10/21/2016 a notification was emailed to the affected users informing them that Assay protocol had changed due to a Marketing decision to delete use of EDC, since it was a discontinued device (for over 10 years), creating a tighter assay range, but met QC specification. Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range, Technical Services began an MRA investigation. Investigation verified user complaint, and Lot was quarantined, and Rework action plans using EDC also were initiated for the device. This issue was found at a Users site, via use as system Quality Control material. The investigation focused on potential effects/risks, and cause. This issue was found at a Users site, via use as system Quality Control material. Customers reported a narrow assay range when compared to prior lots forcing some users out of the provided assay range. PUBLIC CONTACT: Title: Technical Services Manager Address: 1530 Lindbergh Drive, Beaumont, TX 77707 Telephone #: (409) 842-3714 x1177 Email: [email protected]
Quantity in commerce: 65 kits
Distribution: Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2434-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2434-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code JJY

K821982Class ITitan Gel Serum ControlHelena Laboratories / cleared 1982-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)