PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.
FDA Recall Z-3185-2018 · Posted None
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Recall StatusTerminated
Product CodeJHX
Date Initiated2018-04-30
Date Terminated2019-04-17
Product Quantity272 KITS in total
Reason for Recall
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.
Firm Action
The firm, Polymedco, initiated a recall by telephone and followed with email on 4/30/18 to inform users to inspect the reagent cartridges for evidence of leakage from the ALP well and to discard cartridges that had evidence of leakage. Polymedco will replace any affected reagent cartridges.
If you have any questions, contact Polymedco Technical Support at the
1.800.431.2123 Ext 285.
Root Cause
Process control
Distribution Pattern
US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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