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LYFO DISK™

MICROBIOLOGICS INC. · Model 0199L · UDI-DI 10845357002829

JTR
10
510(k) clearances
2
Adverse events
46
Recalls
9
Facilities

Description

LYFO DISK™ P. aeruginosa ATCC 19429™

Recalls

DateFirmReason
2025-12-02Microbiologics IncAffected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
2025-12-02Microbiologics IncAffected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
2025-12-02Microbiologics IncAffected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
2025-11-13Microbiologics IncSome products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
2025-06-27Microbiologics IncKWIK-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.
2025-06-27Microbiologics IncKWIK-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.
2025-06-17Microbiologics IncAffected 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
2025-05-27Microbiologics IncAffected 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
2024-03-06Microbiologics IncThe positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may o
2023-10-18Microbiologics IncA complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

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Data 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.