Recall Z-0536-2020— Helena Laboratories, Corp.

Name: FDA recall Z-0536-2020
Creator: U.S. Food and Drug Administration
Published: 2018-05-23

Class III · Ongoing

Class III FDA medical device recall by Helena Laboratories, Corp., initiated 2018-05-23. It names one FDA 510(k) clearance: K910706. 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). Reason: 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..

Recalling firm: Helena Laboratories, Corp.
Classification: Class III
Status: Ongoing
Initiated: 2018-05-23
Firm location: Beaumont, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K910706 — COLLAGEN REAGENT CAT. NO. 5368Helena Laboratories·cleared 1991-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.