FDAClass IIFebruary 10, 2016

Bact/alert¿ FA recall: Impurity Out of Spec

BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative…

Why was Bact/alert¿ FA recalled?

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

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?

Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.

Product
BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative…
Recalling firm
bioMerieux, Inc.
Quantity
2741 units in total
Distribution
Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
Recall date
February 10, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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