QC Control Sets for GBS Testing Recalled Due to Contamination
Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.
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: FDA Class II medical device recall with no reported illnesses or injuries. The defect is a functional failure of a quality control reagent—the negative control tests positive for the organism it should test negative for—rather than a direct patient safety hazard. The impact is operational disruption requiring laboratory response.
Plain-English summary
Microbiologics Inc is recalling the Lactobacillus acidophilus negative control (item 0243) contained in QC Sets and Panels (KWIK-STIK Cepheid Xpert GBS QC Set catalog 8164 and Cepheid Smart GBS QC Set catalog 8165). The recall affects 541 units distributed nationwide.
The negative control was found to test positive for Group B Streptococcus (GBS) in some cases. Because this is a negative control, it should test negative for GBS. A positive result indicates contamination and causes the quality control validation to fail.
When the quality control test fails, laboratories cannot confirm that their GBS testing system is functioning correctly. This disruption may result in repeated testing or the need for alternative test methods. Laboratories should check lot numbers 8164-45 (12/16/2015), 8164-46 (12/16/2015), 8164-47 (09/02/2016), 8164-48 (09/02/2016), and 8164-49 (10/03/2016) against their inventory and contact their supplier or Microbiologics Inc if they have affected units.
The recalled product
- Product
- QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae…
- Manufacturer
- Microbiologics Inc
- Category
- Medical Device — Quality Control
- Hazard
- Affected units
- 541
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 (7)
- Catalog Number: 8164
- Lot Number (Expiration Date): 8164-45 (12/16/2015)
- 8164-46 (12/16/2015)
- 8164-47 (09/02/2016)
- 8164-48 (09/02/2016)
- and 8164-49 (10/03/2016)
- UDI: 70845357028623
Distribution
Part of a larger recall action
This product is one of 2 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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