BECKMAN COULTER MicroScan MICroSTREP Plus Panel recall: Contamination
BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller…
Why was BECKMAN COULTER MicroScan MICroSTREP Plus Panel recalled?
Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism Streptococcus pneumoniae (ATCC 49619) during quality control (QC) testing on MICroSTREP plus(R) Panel Type 1 hydrated with Mueller-Hinton Broth with 3% lysed horse blood part number B1015-25 lot number 1005986140.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 1005986140, Expiration date April 1, 2018
- Product
- BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 523 boxes
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Kuwait, South Korea and Saudi Arabia.
- Recall date
- May 23, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)