Recall Z-0426-2021
Epitope Diagnostics, Inc. · initiated October 1, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
Codes / lots: Lot Numbers: P826, P815, P796, P776
Reason for recall
The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 10/01/20, the firm, Epitope Diagnostics Inc. (EDI), sent "URGENT: EDI" Novel Coronavirus COVID-19 IgG ELISA Kit Recall" notices were sent to customers. Customers were asked to do the following: Results where the assay controls do not meet the manufacturer's defined specifications should be considered invalid and repeated with another lot. Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Complete and promptly return the Customer Response Form by Email to: cs@epitopediagnostics.com or Fax to: 858-693-7877. Your notification to your customers may be enhanced by including a copy of this recall notification letter. For customers located within United States, we will ask that you return this affected product to the recalling firm. For customers located outside United States, please destroy the affected product. For any questions, please refer to EDIs Quality Assurance and Regulatory Affairs Manager, Stefanie Dallezotte, by email: lenart@epitopediagnostics.com or by telephone: +1 858 693 7877.
Details
- Recall number
- Z-0426-2021
- Initiated
- October 1, 2020
- Product code
- QKO – Reagent, Coronavirus Serological
- Quantity
- 2886
- Distribution
- U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.
- Recalling firm
- Epitope Diagnostics, Inc., San Diego, CA