Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
FDA Recall Z-2434-2019 · Posted None
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Recalling FirmHelena Laboratories, Inc.
Recall StatusTerminated
Product CodeJJY
Date Initiated2016-10-14
Date Terminated2023-10-12
Product Quantity65 kits
Reason for Recall
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Firm 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]
Root Cause
Process control
Distribution Pattern
Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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