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HARDY DIAGNOSTICS · Model R73BX · UDI-DI 00819398026475

510(k) clearances

Adverse events

Recalls

Facilities

Description

LIM Broth, 2ml fill, 12x80mm plastic tube with red cap, order by the package of 100 For the selective enrichment of Group B Streptococcus (Streptococcus agalactiae) from clinical specimens in a container compatible in the WASP instrument.

Recalls

Date	Firm	Reason
2023-08-14	Remel, Inc	On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
2003-08-11	Becton Dickinson & Co.	Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.

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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.