QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). 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 Blood Culture Identification (BCID) Verification Panel kits with catalog number 0959P containing specific lot numbers. The recalled product is a live culture quality control kit used for testing. Three units of affected lots were distributed worldwide, including across the United States, Puerto Rico, Guam, and numerous countries in Europe, Asia, South America, and the Middle East. The affected lot numbers are 5229-01 (expiring 07/31/2020), 5229-02 (expiring 09/30/2020), and 5229-03 (expiring 09/30/2020).
The recall was issued because tests performed with these lots returned incorrect susceptible results for High Level Gentamicin Synergy when analyzed on the Vitek 2 AST-GP67 card. These lots failed the disk diffusion method used for product release, meaning they did not meet quality standards before distribution. The source document does not specify a remedy or recommended action 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: 3 units Lot/code info: Catalog Number: 5229P; Lot Numbers (Expiration Date): 5229-01 (07/31/2020), 5229-02 (09/30/2020), 5229-03 (09/30/2020); UDI: 70845357038899
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.