Medical Device QC Kit Component Bears Incorrect Expiration Date Label
Microbiologics Inc is recalling KWIK-STI(TM) GBS QC Set components with a mislabeled expiration date. The Lactobacillus acidophilus component was labeled 7/31/2020 instead of 7/31/2022.
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: This Class III medical device recall involves a labeling error with no reported illnesses or injuries. The mislabeled expiration date is a quality issue rather than an immediate safety hazard, consistent with typical Class III recall severity.
Plain-English summary
Microbiologics Inc has recalled KWIK-STI(TM) GBS QC Set components due to an expiration date labeling error. Specifically, the KWIK-STIK(TM) negative control component (catalog number 0243U) is labeled with an expiration date of July 31, 2020, when the correct expiration date should be July 31, 2022.
This labeling error could lead to the product being discarded prematurely when still within its validity period, or potentially used after its true expiration date. QC (quality control) test kits are critical for ensuring the reliability of laboratory testing, so an incorrect expiration date on these components could compromise testing integrity.
The recalled product was distributed nationwide to facilities in Alabama, California, Colorado, Illinois, Maryland, Missouri, Mississippi, New Mexico, Ohio, Oregon, Pennsylvania, Texas, and Vermont. The recall applies to lot number 243-48-5.
The recalled product
- Product
- KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
- Manufacturer
- Microbiologics Inc
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 (8)
- Main Product Codes: Catalog Number: 8164
- Lot Number: 8164-78
- UDI: 70845357028623
- Expiration date: 09/30/2021. Affected Component Codes: Catalog Number: 0243U
- Lot Number: 243-48-5
- UDI: 10845357004083
- Expiration Date on Label: 07/31/2020
- Correct Expiration Date: 07/31/2022.
Distribution
Related recalls
Same manufacturer · Microbiologics Inc
See all →- ModerateCampylobacter control kits recalled because they may fail to recover the organism
FDA (Devices) · 2025-12-31
- 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
- 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 →- ModerateWheel Pros Recalls 549 Avix TrailTek RT Tires for Incorrect Markings
NHTSA · 2026-09-10
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-09
- HighPrince Bakery Recalls Sesame French Bread for Undeclared Allergen
FDA (Food) · 2026-09-09
- ModerateWonton Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09
- SevereFayus Inc. Recalls OLA-OLA Pounded Yam for Undeclared Milk
FDA (Food) · 2026-09-09