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HARDY DIAGNOSTICS · Model R201 · UDI-DI 00819398023191

510(k) clearances

Adverse events

Recalls

Facilities

Description

Phosphate Buffered Saline (PBS), 1.0ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics Phosphate Buffered Saline (pH of 7.5) is recommended as a diluent for quantitative culturing or as a rinsing agent in microbiological, immunological, histological and molecular testing procedures.

Recalls

Date	Firm	Reason
2025-10-23	Becton Dickinson & Co.	The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an erro
2016-01-08	BioMerieux SA	Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked
2014-10-23	Remel Inc	A reagent within the test may return false negative results.
2014-10-23	Remel Inc	A reagent within the test may return false negative results.
2014-03-17	Remel Inc	A reagent contained within the product may return false negative results.
2014-03-17	Remel Inc	A reagent contained within the product may return false negative results.
2014-03-06	BioMerieux SA	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra
2014-03-06	BioMerieux SA	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra
2014-03-06	BioMerieux SA	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra
2014-03-06	BioMerieux SA	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra

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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.