Recall Z-0536-2020

Helena Laboratories, Corp. · initiated May 23, 2018

Class III Open, Classified

Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws

Product

Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

Codes / lots: Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369 (Aggregation kit containing Collagen), Exp. 11/30/18 Kit Lot # 5-17-5368 (Aggregation Kit containing Collagen), Exp. 05/31/2019

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.

FDA-determined cause: Unknown/Undetermined by firm

Action taken

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 JJONES@HELENA.COM. For questions, contact Jessica W. Jones, MD, MPH - Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177

Details

Recall number
Z-0536-2020
Initiated
May 23, 2018
Product code
GHR – Reagent, Platelet Aggregation
Quantity
383 Collagen 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
Recalling firm
Helena Laboratories, Corp., Beaumont, TX

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0537-2020 Class IIICollagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies…Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent… 05/23/2018Open, Classified