Z-0537-2020Class III

Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen...

Name: Z-0537-2020 Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen...
Creator: Helena Laboratories, Corp.
Published: 2018-05-23
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2018-05-23 / Open, Classified / root cause: packaging

FDA source

Helena Laboratories, Corp. began a recall of Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use on 2018-05-23. FDA classified it as Class III and gives the reason as "Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0537-2020
Classification: Class III
Status: Open, Classified
Initiated: 2018-05-23
Posted: 2019-11-22
Recalling firm: Helena Laboratories, Corp.
Product: Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
Product code: GHR Reagent, Platelet Aggregation
Reason for recall: Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: On 05/23/2018, the firm's technical services contacted consignees via phone call with a email follow-up of their recall notification letter. Consignees were advised of the following: 1. Prevent any shipment or schedule demonstrations with these lots 2. Remove the lots from available inventory and discard COLLAGEN vials. 3. Verify amount REMOVED FROM STOCK 4. COMPLETE THE FORM AND RETURN TO HELENA LABORATORIES, USA VIA: fax: 409-842-1874 OR E-MAIL TO [email protected]. For questions, contact Jessica W. Jones, MD, MPH - Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177
Quantity in commerce: 64 Aggregation Kits
Distribution: US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan
Product codes and lots: Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0537-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0536-2020	Class III	Ongoing	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0537-2020	Class III	Ongoing	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code GHR

K910706Class IICollagen Reagent Cat. No. 5368Helena Laboratories / cleared 1991-05-20

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)