Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
- Company
- Helena Laboratories, Corp.
- Recall Initiated
- May 23, 2018
- Recall Number
- Z-0537-2020
- Quantity
- 64 Aggregation Kits
- Firm Location
- Beaumont, TX
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.
Distribution
US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan
Lot / Code Info
Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369
Root 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