Recall Z-0585-2022
Microbiologics Inc · initiated February 18, 2020
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: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Codes / lots: a. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-94-3 (04/30/2020), 959-95-2 (09/30/2020), 959-96-1 (12/31/2020), 959-96-4 (12/31/2021), 959-97-4 (03/31/2021), 959-97-5 (03/31/2021); b. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-94-2 (04/30/2020), 959-95-1 (09/30/2020), 959-95-5 (09/30/2020), 959-96-3 (12/31/2020), 959-97-1 (03/31/2021), 959-97-6 (03/31/2021);
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.
FDA-determined cause: Process design
Action taken
Microbiologics notified customers on about 02/18/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions included the following: 1. REVIEW lab procedures to understand how thisinformation affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3. COMPLETE the response form provided; 4. RETURN the response form to recall@microbiologics.com; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Technical Support team at 320.229.7045 or recall@microbiologics.com.
Details
- Recall number
- Z-0585-2022
- Initiated
- February 18, 2020
- Posted by FDA
- February 8, 2022
- Terminated
- July 11, 2022
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 1,975 units
- 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…
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0586-2022 Class II | LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-0587-2022 Class II | QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-0588-2022 Class II | QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-0589-2022 Class II | QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |