Microbiologics Gram-Positive Blood Culture Control Panel Recall for Hydration Fluid Change
Microbiologics Inc is recalling 810 units of the Gram-Positive Blood Culture Control Panel because the recommended hydration fluid has changed to sterile DI water or pH 7.2 phosphate buffer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a procedural change in recommended hydration fluid rather than a direct physical defect or contamination.
Plain-English summary
Microbiologics Inc is recalling 810 units of the Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180. The affected lots are 8180-46, 8180-47, 8180-48, 8180-49, 8180-50, 8180-51, and 8180-52. These products are used in test systems to estimate test precision and detect systematic analytical deviations.
The recall is issued because the recommended hydration fluid for the product has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer. The agency has classified this as a Class II recall.
The products were distributed nationwide, including Washington DC, and internationally to Germany and the Netherlands. Users should stop using the affected lots and contact the manufacturer for instructions regarding the updated hydration fluid requirements.
The recalled product
- Product
- Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 810
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
Distribution
Related recalls
Same manufacturer · Microbiologics Inc
See all →- ModerateCampylobacter six-pack control kits recalled over failure to recover the organism
FDA (Devices) · 2025-12-31
- ModerateCampylobacter LYFO DISK controls recalled over failure to recover the organism
FDA (Devices) · 2025-12-31
- ModerateCampylobacter control kits recalled because they may fail to recover the organism
FDA (Devices) · 2025-12-31
- ModerateCulture media quality control kits recalled over mislabeled lot numbers on pouches
FDA (Devices) · 2025-12-10
- ModerateLYFO-DISK M. canis single packs may fail to recover the organism
FDA (Devices) · 2025-08-06
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighQC Blood Culture Identification Panel Recall for Incorrect Antibiotic Susceptibility Test Results
FDA (Devices) · 2022-02-16
- ModerateMycoplasma genitalium Control Panel Distributed Without Proper Release Testing
FDA (Devices) · 2022-03-23
- HighKWIK-STIK Quality Control Sets recalled for potential bacterial contamination
FDA (Devices) · 2022-02-16
- ModerateMicrobiologics Recalls Vaginal Verification Panel Due to Contamination
FDA (Devices) · 2020-02-12
- ModerateMedical Device Reference Standard Recalled for Inadequate Quality Control Process
FDA (Devices) · 2022-04-27
- ModerateQC Control Sets for GBS Testing Recalled Due to Contamination
FDA (Devices) · 2022-03-09