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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: 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
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