CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Pathfast Myoglobin II reagent cartridge recalled
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products is recalling Pathfast Myoglobin II reagent cartridge, distributed in 8 states. The recall was initiated on 30 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3185-2018
- FDA event ID
- 80724
- Recalling firm
- Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Cortlandt Manor, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2018
- FDA classified
- 17 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Apr 2018 | Recall initiated by company | |
| 17 Sep 2018 | Classified by FDA | +140 days |
| 26 Sep 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
ArkansasCaliforniaFloridaIdahoLouisianaMinnesotaNew YorkTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Where was it sold?
US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 80724| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pathfast NTproBNP recalled by Polymedco, Inc.,/Polymedco | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products | Packaging Defects | 8 states |
More recalls from Polymedco, Inc.,/Polymedco Cancer Diagnostic Products
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | OC-Auto Fobt-chek Negative Controls is the negative recalled | Polymedco, Inc. / Polymedco Cancer Diagnostic Products | Labeling Errors | 47 states |
| Device | CLASS II | Pathfast NTproBNP recalled by Polymedco, Inc.,/Polymedco | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products | Packaging Defects | 8 states |
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