MicroScan Pos Combo Panel Type 33 recall
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent…
Why was MicroScan Pos Combo Panel Type 33 recalled?
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
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?
2016-04-29 2016-05-04 Part No. B1017-211
- Product
- MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 2,706 units total (1,276 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
- Recall date
- January 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)