Recall Z-0589-2022
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
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
Codes / lots: Catalog Number: 5229P; Lot Numbers (Expiration Date): 5229-01 (07/31/2020), 5229-02 (09/30/2020), 5229-03 (09/30/2020); UDI: 70845357038899
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-0589-2022
- Initiated
- February 18, 2020
- Posted by FDA
- February 8, 2022
- Terminated
- July 11, 2022
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 3 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-0585-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| 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 |