Z-0106-2019Class II

"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein...

Name: Z-0106-2019 "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein...
Creator: Helena Laboratories, Inc.
Published: 2017-04-04
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2017-04-04 / Terminated / root cause: labeling and UDI

FDA source

Helena Laboratories, Inc. began a recall of "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... on 2017-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0106-2019
Classification: Class II
Status: Terminated
Initiated: 2017-04-04
Posted: 2018-10-12
Terminated: 2020-05-14
Recalling firm: Helena Laboratories, Corp.
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"
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 3 kits
Distribution: International distribution to country of: Jordan
Product codes and lots: 3-16-5292; UDI: Primary DI - M52552920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0106-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0106-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-12

Product code GGP

K972482Class IIReaads Protein S Antigen Test KitReaads Medical Products, Inc. / cleared 1997-08-13

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)