FDA Medical Device Recalls (openFDA)
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc: 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.
- Recall number
- Z-3185-2018
- Recalling firm
- Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-04-30
- Posted
- not on file
- Terminated
- 2019-04-17
- Reason
- 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.
- Root cause
- Process control
- 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.
- Quantity
- 272 KITS in total
- Distribution
- US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
- Lot, serial or model codes
- Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
- 510(k) numbers
- ["K081360"]
- PMA numbers
- not on file
- Product code
- JHX
- Firm FEI
- 1000119795
- Firm city
- Cortlandt Manor
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28