Beckman Coulter MicroScan Pos Combo Panel Type 43 Recalled for Incorrect Moxifloxacin Dilution
Beckman Coulter is recalling MicroScan Pos Combo Panel Type 43 because an incorrect Moxifloxacin dilution sequence may cause inaccurate antimicrobial susceptibility results.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when they involve potential for medically reversible health consequences or significant diagnostic errors.
Plain-English summary
Beckman Coulter Inc. is recalling 686 boxes of MicroScan Pos Combo Panel Type 43 (Catalog number B1017-217). The product is used to determine antimicrobial agent susceptibility and identify specific bacteria, including Listeria monocytogenes. The recall is due to an incorrect drug dilution sequence for Moxifloxacin printed on the panel, which may result in incorrect Minimum Inhibitory Concentration (MIC) results for Moxifloxacin.
The affected product, identified by Lot 2018-11-03, was distributed to facilities in New Jersey, Texas, Iowa, Pennsylvania, Florida, Nebraska, Ohio, New York, California, Missouri, Oklahoma, and Louisiana. This recall is classified as Class II by the FDA, indicating a situation where use of the product could, in most cases, cause temporary or medically reversible health consequences.
Healthcare facilities and laboratories should stop using the affected MicroScan Pos Combo Panel Type 43 units and contact Beckman Coulter for instructions on returning the product or obtaining a replacement. Users should verify the lot number on their inventory to determine if they are affected.
The recalled product
- Product
- MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 686
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 (1)
- Lot 2018-11-03
Distribution
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