Microbiologics recalls Gram-Positive Blood Culture Control Panels (Catalog #8180) due to incorrect hydration fluid specification. This may affect test accuracy in medical labs. No immediate action needed but verify your product model.
The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.
Microbiologics is recalling Gram-Positive Blood Culture Control Panels (Catalog #8180) because the recommended hydration fluid changed from sterile saline or blood culture media to sterile DI water or phosphate buffer. This could affect test accuracy in medical labs if the wrong fluid is used.
The recall is for a change in the recommended hydration fluid. Previously, sterile 0.85% saline or sterile blood culture media was specified, but now it should be sterile DI water or pH 7.2 phosphate buffer. Using the wrong fluid could lead to inaccurate test results.
Medical labs using Microbiologics Gram-Positive Blood Culture Control Panels (Catalog #8180) with lot numbers 8180-46 through 8180-52 are most at risk. These panels are used in test systems to estimate precision and detect analytical deviations.
Check for the product name 'Gram-Positive Blood Culture Control Panel (Inactivated Pellet)' and catalog number 8180. The affected lot numbers are 8180-46 through 8180-52.
Verify your panel's catalog number and lot number to confirm if it's affected (catalog #8180, lots 8180-46 to 8180-52).
The recommended hydration fluid changed from sterile 0.85% saline or blood culture media to sterile DI water or pH 7.2 phosphate buffer. Using the wrong fluid could affect test accuracy.
No immediate action is needed. The recall is for verification of the correct hydration fluid, not a safety hazard. Check your product details to confirm if it's affected.
Check your panel's catalog number and lot number. If it's catalog #8180 with lots 8180-46 to 8180-52, verify the correct hydration fluid before use.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-0812-2020 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-0812-2020 from Microbiologics. 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.
