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Class 2 Device Recall BacT/ALERT |
 |
| Date Initiated by Firm |
August 17, 2006 |
| Date Posted |
December 05, 2006 |
| Recall Status1 |
Terminated 3 on December 08, 2009 |
| Recall Number |
Z-0243-2007 |
| Recall Event ID |
36239 |
| 510(K)Number |
K021123
|
| Product Classification |
Culture bottle (anaerobic) - Product Code MDB
|
| Product |
bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790 |
| Code Information |
Lot number 1013177 (Product No. 259790) |
Recalling Firm/
Manufacturer |
bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
|
Manufacturer Reason
for Recall |
Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.
|
FDA Determined
Cause 2 |
Other |
| Action |
Affected Customers were notified of this recall on August 18, 2006 and August 21, 2006 via phone and instructed to destroy product remaining in stock. |
| Quantity in Commerce |
34,440 |
| Distribution |
Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV. |
| Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = MDB and Original Applicant = BIOMERIEUX, INC.
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