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U.S. Department of Health and Human Services

Class 3 Device Recall Anaerotest

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 Class 3 Recall
Anaerotest
see related information
Date Posted February 17, 2007
Recall Status1 Terminated on June 06, 2008
Recall Number Z-0499-2007
Recall Event ID 37215
Product Classification Transport Systems, Anaerobic - Product Code JTX
Product Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany
Code Information Item # 1.15112.0001 Lot # OC553145
Recalling Firm/
Manufacturer
EMD Chemicals Inc
480 S Democrat Rd
Gibbstown, New Jersey 08027-1239
Consumer Instructions Contact the recalling firm for information
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
DESIGN: Packaging Design/Selection
Action A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.
Quantity in Commerce 800 packages of 50 strips each.
Distribution Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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