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.
What this means for you
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02