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LYFO DISK™
MICROBIOLOGICS INC. · Model 0626L · UDI-DI 10845357014792
10
510(k) clearances
2
Adverse events
46
Recalls
9
Facilities
Description
LYFO DISK™ K. oxytoca ATCC 49131™
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-02 | Microbiologics Inc | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| 2025-12-02 | Microbiologics Inc | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| 2025-12-02 | Microbiologics Inc | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| 2025-11-13 | Microbiologics Inc | Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. |
| 2025-06-27 | Microbiologics Inc | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. |
| 2025-06-27 | Microbiologics Inc | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. |
| 2025-06-17 | Microbiologics Inc | Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the |
| 2025-05-27 | Microbiologics Inc | Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packa |
| 2024-03-06 | Microbiologics Inc | The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may o |
| 2023-10-18 | Microbiologics Inc | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.