QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling KWIK-STIK AST-GP quality control kits (Catalog Number 5220P) distributed worldwide because they returned incorrect susceptible results when tested. Specifically, the High Level Gentamicin Synergy value was out of specification (showing sensitive when it should not have), and these lots failed the disk diffusion method used for product release testing. The recall affects 139 units across six lot numbers with expiration dates ranging from April 30, 2020 through January 31, 2021.
The recall applies to products distributed in the United States, including Puerto Rico and Guam, as well as numerous international locations including Australia, Canada, Japan, and many others. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
Reason for recall: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release. Distribution: Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, Quantity: 139 units Lot/code info: Catalog Number: 5220P; Lot Numbers (Expiration Date): 5220-01 (04/30/2020), 5220-02 (07/31/2020), 5220-03 (10/31/2020), 5220-04 (10/31/2020), 5220-05 (10/31/2020), 5220-06 (01/31/2021); UDI: 70845357026551
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.