Recall Z-0537-2020
Helena Laboratories, Corp. · initiated May 23, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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,
Codes / lots: Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369
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.
FDA-determined 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
Details
- Recall number
- Z-0537-2020
- Initiated
- May 23, 2018
- Product code
- GHR – Reagent, Platelet Aggregation
- 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
- Recalling firm
- Helena Laboratories, Corp., Beaumont, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0536-2020 Class III | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies…Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent… | 05/23/2018Open, Classified |