Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX Outer labeling of Substrate (brown bottle and cap): "Substrate 13 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26" Outer Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid): "Protein S Conjugate 12 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26"

FDA Recall Z-0106-2019 · Posted None

Recalling FirmHelena Laboratories, Inc.
Recall StatusTerminated
Product CodeGGP
Date Initiated2017-04-04
Date Terminated2020-05-14
Product Quantity3 kits

Reason for Recall

Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.

Firm Action

On 4/4/17, an email notification was initially sent to the firm's OUS distributor that received 3 kits. On 4/10/17, the customer replied with a photograph to confirm their kits were affected. A Withdrawal notice was approved internally, and formally issued by the firm to a single distributor via e-mail on 4/17/17. An authorized confirmation of destruction was sent from the distributor to the firm via e-mail on 4/18/17. The firm's public contact may be reached at (409) 842-3714 ext. 1177.

Root Cause

Labeling mix-ups

Distribution Pattern

International distribution to country of: Jordan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972482REAADS PROTEIN S ANTIGEN TEST KITReaads Medical Products, Inc. · 1997-08-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑