Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing
A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.
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 is an FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. While GBS is a high-risk pathogen, the defect is a quality control testing failure rather than direct patient exposure. The hazard is operational—compromised testing reliability.
Plain-English summary
Microbiologics Inc is recalling quality control sets designed for Group B Streptococcus (GBS) diagnostic testing. The negative control material in these sets (specifically item 0243, a Lactobacillus acidophilus control) is testing positive for GBS in some cases, which is incorrect. When the negative control tests positive, it causes the quality control test to fail.
The recalled products are the Cepheid Xpert GBS QC Set (catalog 8164) and Cepheid Smart GBS QC Set (catalog 8165). These quality control sets have been distributed nationwide across 29 states. The specific recalled lot is 8165-25 with an expiration date of June 16, 2016.
The failure of the quality control test disrupts laboratory operations and may require laboratories to repeat testing or use alternative testing methods. Compromised quality control materials can undermine the reliability of diagnostic testing if the defect is not detected. The false-positive results in the negative control prevent proper verification of the diagnostic systems' accuracy.
The recalled product
- Product
- QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Grou
- Manufacturer
- Microbiologics Inc
- Hazard
- quality-control-failure
- false-positive
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 (3)
- Catalog Number: 8165
- Lot Number (Expiration Date): 8165-25 (06/16/2016)
- UDI: 70845357028630
Distribution
Distributed nationwide across the United States.
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