Recall Z-1686-2016
Diamedix Corporation · initiated October 20, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Codes / lots: Lot # 30804, Catalog # 720-600 Expiration Date April 30, 2015
Reason for recall
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
The firm, Diamedix, sent letters dated October 14, October 20 and December 5, 2014 to its customers directly informing them of the correction action. Notification of all domestic customers via Certified Mail. Notification fo the international customers via Federal Express and/or e-mail. With the letter, a replacement bottle of Sample B Diluent was sent and the customer was advised to discard any unused bottles of affected product. New lot number labels were provided to identify kits with the replacement Sample B Diluent. Customers with questions were told they could contact Diamedix Technical Services (1-800-327-4565) if they had any questions or required any additional guidance regarding the correction.
Details
- Recall number
- Z-1686-2016
- Initiated
- October 20, 2014
- Terminated
- December 14, 2016
- Product code
- LSE – Epstein-Barr Virus, Other
- Quantity
- 588 kits
- Distribution
- Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
- Recalling firm
- Diamedix Corporation, Miami Lakes, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1685-2016 Class II | Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure…A gel-like substance was found in kit component, sample diluent , that could potentially compromise product… | 10/20/2014Terminated |
| Z-1687-2016 Class II | Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure…A gel-like substance was found in kit component, sample diluent , that could potentially compromise product… | 10/20/2014Terminated |