Recall Z-0714-2022
Microbiologics Inc · initiated October 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Codes / lots: Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 before UDI was required for class 1 IVDs) Lot Number (Expiration Date): 959-74-1 (10/08/2014), 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015)
Reason for recall
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
FDA-determined cause: Nonconforming Material/Component
Action taken
Microbiologics notified customers on about 10/06/2014 via letter titled "E.faecalis Gentamicin Susceptibility Notification." Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall, it is recommended that the intended use of the organism be reviewed to determine if Gentamicin synergy results have an impact on use. It is recommended to discard these lots if an impact is to be expected. Questions or concerns can be directed to the Technical Support team at 320.229.7064 or techsupport@microbiologics.com.
Details
- Recall number
- Z-0714-2022
- Initiated
- October 6, 2014
- Terminated
- January 17, 2023
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 150 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South…
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0712-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | 10/06/2014Terminated |
| Z-0713-2022 Class II | LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | 10/06/2014Terminated |