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U.S. Department of Health and Human Services

Class 2 Device Recall Free and Total Protein S ELISA Kit

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 Class 2 Device Recall Free and Total Protein S ELISA Kitsee related information
Date Initiated by FirmApril 04, 2017
Create DateOctober 12, 2018
Recall Status1 Terminated 3 on May 14, 2020
Recall NumberZ-0106-2019
Recall Event ID 81024
510(K)NumberK972482 
Product Classification Test, qualitative and quantitative factor deficiency - Product Code GGP
Product"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"
Code Information 3-16-5292; UDI: Primary DI - M52552920
FEI Number 1618982
Recalling Firm/
Manufacturer		 Helena Laboratories, Inc.
1530 Lindbergh Dr
Beaumont TX 77707-4131
For Additional Information ContactDr. Jessica Jones Hanka
409-842-3714 Ext. 1177
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn 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.
Quantity in Commerce3 kits
DistributionInternational distribution to country of: Jordan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = GGP
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