KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
FDA device recall Z-2576-2023 · posted 2023-09-11 · Open, Classified
Recall details
- Recalling firm
- Microbiologics Inc
- Reason for recall
- One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
- Action taken
- Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- JTR
- Quantity affected
- 4 units
- Distribution
- US Nationwide distribution in the states of MN, PA, TN, TX.
- Date initiated
- 2023-08-14
- Date posted
- 2023-09-11
- Location
- Saint Cloud, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |