Date Initiated by Firm |
August 17, 2006 |
Date Posted |
February 17, 2007 |
Recall Status1 |
Terminated 3 on June 06, 2008 |
Recall Number |
Z-0498-2007 |
Recall Event ID |
37215 |
Product Classification |
Micro Test Rolls - Product Code J TX
|
Product |
Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928 |
Code Information |
Item number 1.19034.0002 Lot # OC553145 |
Recalling Firm/ Manufacturer |
EMD Chemicals Inc 480 S Democrat Rd Gibbstown NJ 08027-1239
|
For Additional Information Contact |
Joseph Scheollkopff 856-423-6300
|
Manufacturer Reason for Recall |
Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
|
FDA Determined Cause 2 |
Other |
Action |
A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return. |
Quantity in Commerce |
8 rolls |
Distribution |
Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico. |
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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.
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