Recall Z-0537-2020 ยท GHR Reagent, Platelet Aggregation
Helena Laboratories, Corp.
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
| Date | May 23, 2018 |
| Status | Open, Classified |
| 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. |
| 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 JJONES@HELENA.COM. For questions, contact Jessica W. Jones, MD, MPH - Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910706 | COLLAGEN REAGENT CAT. NO. 5368 Helena Laboratories, May 20, 1991 |