QC Sets and Panels, KWIK-STIK AST-GP (4 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 QC Sets (Catalog Number 5112P, Lot Numbers 5112-01 and 5112-02) used for quality control testing in microbiology laboratories. The recalled product contains four bacterial strains and was distributed worldwide. Testing revealed that the High Level Gentamicin Synergy value in these lots was out of specification when analyzed on Vitek 2 AST-GP67 cards, causing tests to return incorrect susceptible results. The affected lots also failed the disk diffusion method used for product release testing.
A total of 10 units were distributed across numerous countries including the United States, Puerto Rico, Guam, Canada, Australia, and countries throughout Europe, Asia, and Latin America. The recall source does not specify what consumers or affected laboratories should do regarding this product.
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: 10 units Lot/code info: Catalog Number: 5112P; Lot Numbers: 5112-01 (Expiration Date 07/31/2020), 5112-02 (Expiration Date 10/31/2020); UDI: 70845357026551
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.