QC Blood Culture Identification Panel Recall for Incorrect Antibiotic Susceptibility Test Results
Microbiologics recalls KWIK-STIK blood culture identification quality control panels due to incorrect susceptibility test results. High-level Gentamicin Synergy values were out of specification, risking inaccurate diagnostic guidance.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving diagnostic inaccuracy. No illnesses or injuries are reported, and the hazard is potential rather than actual. This meets the criterion of 'risk-of-harm products where injury has not yet been reported' for a High severity rating.
Plain-English summary
Microbiologics Inc. is recalling KWIK-STIK Blood Culture Identification (BCID) Verification Panels, catalog number 5229P, used as quality control materials in laboratory diagnostic testing. These panels contain live culture microorganisms used to verify the accuracy of blood culture identification systems.
The recall was initiated because tests using these panels returned incorrect susceptible results. High Level Gentamicin Synergy values were out of specification when analyzed on Vitek 2 AST-GP67 cards, and the affected lots failed the disk diffusion method used for product quality control verification.
The affected panels were distributed worldwide, including the United States, Puerto Rico, and Guam. Laboratories using these panels should immediately discontinue use of the affected lots and contact Microbiologics Inc. for replacement materials or further instructions.
The recalled product
- Product
- QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
- Manufacturer
- Microbiologics Inc
- Affected units
- 3
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 (5)
- Catalog Number: 5229P
- Lot Numbers (Expiration Date): 5229-01 (07/31/2020)
- 5229-02 (09/30/2020)
- 5229-03 (09/30/2020)
- UDI: 70845357038899
Distribution
Part of a larger recall action
This product is one of 5 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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