FDA · Medical device recall

Platelet Aggregation Kit… and 1 more product

Dec. 4, 2019 Class III

Date: Dec. 4, 2019
Risk class: Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
Status: Ongoing
Filed by: Helena Laboratories, Corp.
Distribution pattern: US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan

2 products in this recall

Platelet Aggregation Kit…

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.
Quantity: 383 Collagen Kits
Codes and 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
Recall started: May 23, 2018
Device type: Reagent, Platelet Aggregation
Root cause (FDA): Unknown/Undetermined by firm
What the company told customers: 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
Recall number: Z-0536-2020

Collagen Reagent…

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.
Quantity: 64 Aggregation Kits
Codes and lots: Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369
Recall started: May 23, 2018
Device type: Reagent, Platelet Aggregation
Root cause (FDA): Unknown/Undetermined by firm
What the company told customers: 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
Recall number: Z-0537-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0536-2020, Z-0537-2020. The agency record governs; check it and the company before acting.

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