Recall Z-0537-2020— Helena Laboratories, Corp.
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: Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,. 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 recordK-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
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
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.