Polymedco recalls PATHFAST Myoglobin II reagent cartridges with a pinhole causing leakage, potentially leading to inaccurate test results. Affected units may have measurement errors up to +20%.
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.
Polymedco is recalling PATHFAST Myoglobin II reagent cartridges that may have a pinhole causing leakage. This could lead to test results being up to 20% higher than actual values, which might affect cancer diagnosis accuracy.
A pinhole in the aluminum sheet over the reagent wells can cause leakage. This leakage leads to higher measurement values, potentially up to 20% more than the true value, which could impact cancer test accuracy.
Users of PATHFAST Myoglobin II reagent cartridges for cancer diagnostics are affected. Those using the recalled cartridges for blood tests may see inaccurate results.
Check for the catalog number PF1111-K on the cartridge. The affected lot is T738, which expires June 30, 2018.
Inspect the cartridge for a pinhole in the aluminum sheet over the reagent wells.
The catalog number is PF1111-K.
The affected lot T738 expires June 30, 2018.
The pinhole causes leakage, leading to test results that are up to 20% higher than actual values.
We’ve drafted a message you can send Polymedco to request your refund or repair — edit it as you like.
Subject: Recall Z-3185-2018 — Polymedco Polymedco Hello, I own a Polymedco that is covered by recall Z-3185-2018 from Polymedco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
