FDA Medical Device Recalls (openFDA)
Helena Laboratories, Inc.: Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
- Recall number
- Z-2434-2019
- Recalling firm
- Helena Laboratories, Inc.
- Product
- Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
- Status
- Terminated
- Initiated
- 2016-10-14
- Posted
- not on file
- Terminated
- 2023-10-12
- Reason
- Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
- 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: jhanka@helena.com
- Quantity
- 65 kits
- Distribution
- Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K821982"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28