QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that
FDA device recall Z-0589-2022 · posted 2022-02-08 · Terminated
Recall details
- Recalling firm
- Microbiologics Inc
- 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.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JTR
- Quantity affected
- 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, Egyp
- Date initiated
- 2020-02-18
- Date posted
- 2022-02-08
- Date terminated
- 2022-07-11
- Location
- Saint Cloud, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |